Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens healthcare diagnostics has identified that it takes 24 minutes of incubation prior to processing the samples on the immulite/immulite 1000 system for the patient sample and the pre-treatment solution to reach full equilibration when using pre-treatment solution (lgfa) lot 055 contained in igf-i kit lot 411. if patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. if the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed.Quality controls (qc) will not detect this issue. there is the potential for a falsely depressed igf-i value to delay the diagnosis of acromegaly and/or delay potential pharmacologic treatment to normalise serum igf-i.
Action
Siemens is advising users that the affected lot can continue to be used, however users should ensure the pre-treatment solution is allowed to incubate with the patient samples for a minimum of 24 minutes prior to processing.
A review of previously generated results is at the discretion of the laboratory. This action has been closed out on 14 June 2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Allegra orthopaedics is performing a recall of specific lot numbers of the pf6 tube assembly which is a component of the peripheral vascular infusion/aspiration catheter or “pad” catheter. this is the only component of the pad affected by this recall action as this is the component that is ethylene oxide sterilised.Following a review of the validation of the ethylene oxide sterilisation process for the pf6 tube assembly, it was apparent that there is insufficient evidence to demonstrate that a sterility assurance level (sal) of at least 10-6 was achieved.
Action
Allegra Orthopaedics is advising users to inspect stock and quarantine any remaining units of the affected devices for return.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer is providing users with additional safety instructions for the safe use of the magnetic resonance system g-scan brio. if not addressed, the issue described could lead to an unsafe exam condition.A potential weakness in the foot rest and the left bed rail of the patient table has been identified. this weakness may lead to a fracture of the patient table within the foot rest and the left bed rail in certain conditions. in particular this may happen if a heavy patient applies a strong dynamic stress (bouncing stress) to that part of the table to access or descend from the bed. there is a chance of a patient falling, or patient injury to the head or back if this situation occurs. there have been no reports of injuries as a result of this issue.
Action
Emergo is providing users with work around instructions to follow to prevent the issue from occurring. The Instructions for Use (IFU) will be updated to include the additional information. This action has been closed-out on 13/10/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a limited number of complaints where the bolts under the stretcher became loose. there has been one minor injury as a result of a patient falling related to these incidents. arjohuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
Action
ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU).
ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Carestream health has identified a software issue related to image orientation. if the image suite software receives a computed tomography (ct) or magnetic resonance (mr) image with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the left (l) and right (r) and anterior (a) and posterior (p) overlay text will be displayed opposite. that is, the left side is marked r and the right marked l and the anterior marked p and the posterior marked a. this could result in delays in a misdiagnosis or improper patient care.There has not been any diagnosis errors reported.
Action
Carestream Health Australia will contact the affected customers to update the software on the device to correct this issue.
In the interim, until the software update has occurred, customers who use Image Suite for CT or MR images should make users aware of the problem and take additional steps to check correct orientation of any markers. A review of past patients’ results is recommended at the discretion of the clinical director/radiologist.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Ge healthcare has become aware that an out of tolerance torque tool was used on three joints on your revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artefact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.
Action
GE Healthcare is advising users that the scanner can continue to be used. If the X-ray Tube joint loosens, the system would fail internal checks and cause the previous mentioned hazards of beam tracking errors, potential scan aborts and/or image artefacts, requiring immediate action by service to realign the system. Should this occur, stop using the system and call the service team to bring the system back into proper operational status.
GE Healthcare will be correcting all affected products. This action has been closed-out on 27/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
An investigation of customer complaints has determined that in rare cases, it is possible for the thinprep 5000 processor with autoloader to misread the value encoded in the vial barcode label. this occurs when the barcode scanner decodes a value that meets all symbology rules and check-digit validation but is not the intended value encoded in the barcode and processes the vial using this identifier. this potential is only present in thinprep 5000 processor with autoloader configurations and is not present in the benchtop configuration. in an autoloader configuration, if a misread occurs, the misread vial id value is transferred to the slide and a slide is produced with the incorrect identifier. there is a risk of misidentification of a patient slide.
Action
Hologic is advising users to ensure the labels are graded against the appropriate standard. The Technical Information Reference Guide has been updates to clarify the barcode quality and specification requirements.
Hologic is providing users with a software update to perform additional safety reads to improve identification of inadequate labels.
Hologic is also providing users with updated barcode scanners. This action has been closed out on 19/01/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Medtronic has confirmed 4 instances of loss of therapy during the recharging of a restoresensor implantable neurostimulator, at a rate of 0.007% worldwide. by design, stimulation therapy turns off when the battery voltage depletes below 3.575 volts (< 0% battery level). insufficient coupling (charging efficiency) between the recharger & the implant during the recharge session was found to be a key factor in the reported events which consequently led to the inadequate recharge of the battery & subsequent loss of stimulation therapy. if the insufficient recharge coupling is continued & the battery is not recharged to restart stimulation therapy, the battery can discharge to an over discharge (od) state. under normal use conditions, the patient has 30 days to recharge the device to avoid experiencing a battery od state. in this scenario, this time period is reduced to 1–2 days. if three occurrences of od occur, the implant will trigger end of life, and must be replaced to restore therapy.
Action
Medtronic advises patients to follow the current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger, specifically:
- Check the neurostimulator battery charge level once a day or more frequently as needed.
- Keep the neurostimulator sufficiently charged to maintain therapy. It can be charged at any time; users do not need to wait for a low battery message.
- During neurostimulator recharging, monitor the Charging Efficiency row and adjust the antenna to obtain as many solid black boxes as possible. If only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger.
- During recharging, ensure the neurostimulator Battery Charge Level is at least 25% before ending the charge session. However, a full battery charge is ideal.
- Medtronic is working with the TGA to assess the best approach to resolve the reported issue. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Alcon is conducting a recall for product correction of all lensx laser systems with corneal flap capability after receiving reports concerning incomplete corneal flap creation, which manifests as un-dissected area(s) within the side cut. if an un-dissected area in the side cut is observed, it may cause difficulty lifting the flap, potentially resulting in corneal tear, irregular stromal bed, or a corneal epithelial defect. this issue has been confirmed to manifest in only a small number of systems through the normal installation setup and optimisation process.
Action
Alcon is advising users that the LenSx system can continue to be used, and to exercise professional medical judgement when determining the management of potential side cut issues. Alcon will be implementing a software upgrade in order to minimise any incomplete areas within the side cut. This action has been closed-out on 03/02/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Bard access systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the replacement connector for groshong nxt picc (for use with groshong nxt, 5 fr. dual-lumen picc). the case label for the specific lot incorrectly identified the connector colour as “white”. the connector is red and is correctly identified by the unit label as “red”.
Action
Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The plastic enclosure used in the maxi air supply motor for models 230v is not fire retardant. this can be seen by the "arrows" on the moulded part and was confirmed by an ad-hoc flammability test. this may increase the risk of a fire spreading.
Action
An ArjoHuntleigh representative will attend the affected hospital to replace the affected blower unit.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following a field action on a single lot of architect stat high sensitive troponin-i reagent in january, which impacted only selected countries. as a result, abbott has identified a potential for increased calibration failures prior to the expiration date. there is no impact to generated patient results. there is a potential for delay in results due to calibration errors and failure to calibrate which may lead to delayed treatment of life threatening injury.
Action
Abbott is advising users that for certain lots, affected products can be used provided the calibration passes. Alternative lots should be ordered as soon as possible, and if the calibration fails to use an alternative lot. Once an unaffected lot is available, any remaining affected lots should be discarded.
For certain lots, the expiration date should be amended as instructed. The expiration date for these lots will need to be manually tracked, as the system will maintain the original expiry date.
Abbott is advising users that all new stock will have the expiry dates lowered to 4 months until corrective actions can be implemented.
This action has been closed-out on 28/02/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
In the event that the product is used with diluents other than those listed, it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
Action
Leica is advising users to only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the specified diluents.
There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. This action has been closed-out on 25/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Boston scientific has determined that certain threader monorail and threader over the wire micro-dilatation catheters were shipped from the australia distribution centre with an international direction for use (dfu) rather than an australian dfu. the australian dfu includes additional warnings and precautions included in the ‘precaution’ section of the dfu.
Action
Boston Scientific is providing users with the Australian DFU. This action has been closed-out on 17/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens has identified multiple software issues that may affect the day-to-day behaviour and/or workflow of the system.1. all levels of qc run when only 1 is selected in start/restart window 2. changing the display name of an assay deselects that method in its associated qc panel, therefore qc for the renamed assay will not run as part of the panel. 3. a workstation services restart screen may appear under multiple scenarios, causing the user interface to be temporarily inaccessible. the user will be prompted to login once the services restart. a.Workstation services may restart if a user defined filter is created in the test results overview screen that includes the 31st day of the month, but is run in a month that does not have 31 days. b.Workstation services may also restart when all items are removed from the watchlist. 4. the chemistry xpt software does not update assay utilisation counters for ise tests when patient samples and qc samples are run in version v1.1.
Action
Siemens is providing users with work around instructions to follow as an interim measure. A software upgrade will be installed as a permanent correction. Users are advised to review the issues with the Medical Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The affected part and lot numbers of the 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers.The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. if detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.In addition, the potential harm of damage to surrounding structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. a screw that is too long can also result in soft tissue damage (soft tissue irritation) if not recognised during the procedure. at this time there have been no reports of patient involvement.
Action
JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number. This action has been closed out on 19/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer, spacelabs, has received one report of values for patient height and weight being switched when input at the xhibit central station, causing a bedside monitor body surface area (bsa) calculation to be in error. no one has been injured due to this error. in order for the error to occur, the height and weight values must have been entered at the xhibit central station, the cardiac output cable must be attached for use, and the cardiac output function on the bedside monitor must be initiated. the bsa value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as cardiac index. the bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. in situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.
Action
Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction. This action has been closed-out on 27/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens healthcare diagnostics has identified an issue with the advia centaur xpt default setting for the daily maintenance task (or daily cleaning procedure) frequency. instruments may have the daily maintenance task frequency set to “as needed” instead of “daily”. not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results.
Action
Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. there have been no reports of injuries as a result of these issues;- sagittal result shortened for axial head scans.- when axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of mpr images due to the scan series being broken into serval series of images.- scan length changes with a change in field of view (fov).- scan length changes on subsequent axial results.- surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions.- there may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is not possible.
Action
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results. metamizole (dipyrone) has been identified as an interferent which may cause false low results in certain assays. this is a previously undocumented interferent.These interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter and may result in an error in diagnosis or patient management.No customer complaints have been received for this particular issue.
Action
Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences.
A review of previously generated patients results is at the discretion of the Laboratory Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Lima orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors.The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient.
Action
Customers are advised to inspect stocks and quarantine the affected units prior to their return.
This action has been closed out on 20/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Heartware have received reports of loose power and data connectors on the heartware controller, specifically for loose connector ports within the controller.If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures.In these scenarios, potential risks include:- interruption of circulatory support due to a pump stop, which could cause serious injury or death- reduced ability to detect alarms- loss of communication between the controller and heartware monitor.
Action
HeartWare is advising the clinicians to:
1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources.
2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
A firmware anomaly inside the detector (px4343rg) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. this may result in an inadequate acquisition of the x-ray image. if a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.
Action
Philips is providing a software upgrade to version 4.0.5 to permanently correct this issue. This action has been closed-out on 24/05/2017.