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 oxygen sensor for the ventilators has a life of one (1) year from date of manufacture of the sensor, depending on the operating conditions. conflicting information was provided to puritan bennett 840 ventilator customers in a labelling addendum stating that the oxygen sensor should be replaced every two years. if a sensor becomes non-functional during use and cannot be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied level of oxygen from the ventilator and to provide appropriate alarms. a non-functional o2 sensor does not affect the concentration of oxygen delivered from the ventilator and does not control the flow of gases.
Action
Covidien is providing updated labelling to clarify the operational life of the oxygen sensor used in the Puritan Bennett 840 and 700 series ventilators. Coviden is also advising users that if a sensor becomes non-functional and facility protocol requires transfer of a patient to an alternate ventilator, the patient must be clinically evaluated to determine the best conditions for transfer to reduce risk to the patient.
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 incorrect size determination table in surgical technique indicates that the femoral component size c is compatible with a tibial inlay/tibial plateau size 67. however, tibial components size 67 may be correctly used only with the smaller femoral components sizes a or b. the incompatible combination of the balansys cr, uc and ps systems (fixed bearing)may result in the following risks: - there is an immediate risk that the knee cannot be optimally equilibrated, which may lead to pain and instability. - in the long term, there is a risk of increased wear of the polyethylene, which may lead to pain, osteolysis, tibial loosening, instability and revision surgery. in the balansys rp system (rotating platform), there is a risk of increased soft-tissue irritation associated with pain.
Action
Mathys Orthopaedics is advising surgeons and hospitals that the Surgical Technique is incorrect as it indicates that the femoral conmponent size C is compatible with a tibial inlay/tibial plateau size 67. Tibial components size 67 should only be used with smaller femoral components size A and B.
A single patient was implanted with the incorrect combination in Australia. The associated surgeon has been contacted and provided with additional information for the ongoing management of the patient.
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 has completed a software solution to prevent the potential risk of fluid overload or fluid loss caused by repetitive clearing of the balance alarm and providing users with updated instructions for use (ifu).
Action
Baxter is notifying their customers of this problem and advising that repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. The cause of fluid balance alarms must be identified and the fluid rate adjusted accordingly.
A software update will be provided to correct the issue. This action has been closed-out on 19/02/2016.
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
The angle of the locking lever of holding forceps from the affected lots has the incorrect angle and may not lock, resulting in the forceps inability to retain the desired position once applied.
Action
Synthes is advising users to inspect stock and quarantine any affected products to return to Synthes.
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 black foam on the cell fixing plate of older models of spaplus analysers can deteriorate over time which can lead to various faults on the analyser.
Action
In Vitro Technologies is providing their customers with the upgraded Cell Fixing Plate.
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
During the archive procedure, if the system begins to archive images for multiple studies within fractions of a second and an unexpected condition causes the software process restart the following issues may occur:1. incorrect images being displayed for a study retrieved from archive (for example, a study for a different patient being displayed),2. failure to retrieve images for a study from archive.If this issue occurs, two or more studies may be affected. this issue is not immediately evident to the user at the time of archival. it is possible that clinical decisions will be made using an incorrect set of images or an incomplete set of images. this may result in inappropriate care leading to patient harm if unnoticed or a need to retake images.
Action
Device Technologies is providing users with work around instructions 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
It was discovered that the product may set 15 seconds faster than specified in the directions for use. this set time discrepancy may cause the product to set before there is an opportunity to place it in the tooth cavity.
Action
Kerr is requesting users return affected stock for replacement or credit. This action has been closed-out on 11/02/2016.
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
The lcp condylar plates 2.4 of lot 3180479 were labelled with duplicate article numbers instead of the article and lot number. the correct lot number is etched on the plate.
Action
Synthes is requesting users inspect and return any affected stock to Synthes for replacement.
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 lcp plates from the affected lot were mislabelled with an incorrect lot number. the packaging of these plates were labelled as lot 7709267 whereas the lot etched on the plates is 7709265. synthes australia is recalling all lcp plates labelled as lot 7709265 and lot 7709267.
Action
Synthes is requesting users inspect and return any affected stock to Synthes for replacement.
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
Cardiac science has determined that certain powerheart g5 automatic external defibrillators (aeds) shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognise that the pads have been placed on the patient during a rescue attempt. the aed voice prompts will progress until they reach the pads placement (peeled) step. at that point the aed will, regardless of whether the pads are placed onto the patient's chest or not, continuously repeat "place pads firmly onto patient's chest..." after 2 minutes, the pad placement prompting will time out and the aed will begin cpr mode. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death.
Action
Cardiac Science is advising users that affected units will be required to be sent to Cardiac Science's head office for repair. Units will be returned to users the same day they are received by Cardiac Science. This action has been closed-out on 11/04/2016.
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
Zimmer has received 13 complaints since 2007 related to hyper-extension. this represents a complaint rate of approximately 0.4%. of the 13 complaints there were 9 patients involved due to repeat occurrences with multiple patients. in addition, analysis of the explanted polyethylene insert found that it typically exhibited anterior deformation in these 9 patients. based on the investigation of these complaints, zimmer determined that updates to the labelling associated with the zimmer segmental system were required to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
Action
Zimmer is updating the applicable surgical technique (97-5850-004-00) and instructions for use (87-6203-755-23) and is advising surgeons that if a patient is symptomatic with instability or pain associated with hyperextension of approximately 15 degrees or more, surgeon evaluation is recommended. Zimmer is also working on an enhanced design that will be offered in addition to the current polyethylene inserts.
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 philips heartstart xl+ defibrillator/monitor battery may take slightly longer to charge to 100% at 35 deg c than specified in the instructions for use (ifu).
Action
Philips is providing users with an addendum to the Instructions for Use (IFU) specifying the battery charge time and temperature specifications. The addendum specifies the proper battery charge time with the device turned off and PC power connectors i.e., with temperature at 25 deg C (77 deg F), it will take less than 3 hours to charge at100% capacity and less than 2 hours to charge at 80% capacity.
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 solar 8000m/i automatic view on alarm (avoa) feature will stop functioning if the patient monitor is discharged from the cic central station while a remote automatic bedside alarm view is currently being displayed on the solar. once this issue occurs, subsequent remote avoa alarms will not automatically appear on the left side of the solar display. in addition, the user interface menus on the discharged patient monitor will not function correctly. this may result in delayed treatment due to missed alarms that may be serious. this issue can be fixed by rebooting the solar 8000m/i.Parameter, waveforms and alarms associated with the patient directly connected to the solar 8000m/i patient monitor are not affected.
Action
GE Healthcare is advising users that if patients are discharged from the CIC central station to discontinue use of the AVOA feature and is providing instructions to disable the feature. If patients are not discharged from the CIC central station the AVOA feature can continue to be used. This action has been closed-out on 29/01/2016.
GE Healthcare will be implementing a software upgrade for all Solar 8000i / M monitors.
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
Carefusion has identified potential risks with model code 2000e and lot numbers listed due to connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during infusion. an inability to disconnect may require replacement of a line.
Action
Carefusion is requesting users to segregate and return unused stock of connectors with polycarbonate housing to Carefusion.
Polycarbonate materials were introduced because they provide more resistance to isopropyl alcohol than the acrylic housing hub. Now that the 2000E polycarbonate version will no longer be available, please remind staff that when accessing the valve, remember to Swab The Hub every time, do not swab the whole body of the device and take care to follow instructions during connection and disconnection of the SmartSite connector.
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
Abbott medical optics is issuing this hazard alert because certain silicone tecnis iol s may have been labelled with the incorrect diopter power. a mislabelled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention to correct the issue.
Action
AMO Australia is providing the implanting surgeon with advice on the treatment of the patient implanted with the affected 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
Intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the wdr1 are not properly displayed. if the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam or patient. if the user does not notice this change and continues to perform the exam, the images will be placed in the incorrect patient file.
Action
GE Healthcare are providing work around instructions for users to follow when using the WDR1 based systems for exams. Users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure the system did not update and select an incorrect exam. GE is providing a software upgrade as a permanent fix.
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 listed lot numbers of the t-adaptation plate 1.3, 4 holes (221.334) and the t-adaptation plate 1.3, head 3 holes (221.333) were mis-packaged. part number 221.334 was labelled as a 3 hole plate (221.333) instead of a 4 hole plate, whereas part number 221.333 was labelled as a 4 hole plate (221.334) instead of a 3 hole plate.
Action
Synthes is requesting users inspect and return any affected stock to Synthes for replacement
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
Terumo bcthas identified that pinhole leaks may occur due to stresses on the channel weld, particularly during long procedures on spectra optia. if leaks occur during use the procedure must be discontinued.Terumo bct has received reports relating to leaks in the channel of the tubing set of the spectra optia. these leaks have many different causes, including operator misloading. a very specific type of channel leak, a 'pinhole' leak at a specific location reported by customers primarily during long mnc procedures have been identified.
Action
Terumo BCT is installing a modified filler at the next scheduled preventative maintenance to mitigate the risk of leakage. The device can continue to be used while awaiting the replacement filler. Users should be aware of the potential for leakage and cease any procedure if leakage is observed.
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
When moving the stretcher over barriers on the ground, the structure of the frame may deteriorate and finally break which could result in patient injury.
Action
Siemens Healthcare are advising users to cease use of the affected stretchers until it has been reinforced. Siemens Healthcare will be contacting all users to arrange suitable time to install an improvement kit to reinforce the structure of the stretcher.
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
Investigations by the manufacturer have confirmed that dr0802 oxoid legionella penumophila 2-14 reagent, lot 1265366 may return false negative tests. continued use of this lot may result in a delay to the correct serogroup characterisation of legionella isolates.
Action
Thermo Fisher Scientific is advising users to inspect stock and remove all affected lots from use. Thermo Fisher is advising that the requirement for review of patient results should be determined by 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
Axiom artis systems with certain serial numbers are using flat detector cooling unit with inappropriate connectors that may leak. this might cause a system failure resulting in a drop out of the gantry system.
Action
All connectors will be checked for leak tightness and an additional protection unit will be installed by Siemens' technicians. This will prevent leakages in the connector and therefore, the potential drop out of the gantry system can be avoided.
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 potential for incorrect results to be reported when the versacell system drops a sample tube during transfer to the immulite 2000/immulite 2000 xpi automation rack under certain specific conditions. this issue only occurs with versacell systems that are connected to immulite 2000/2000xpi and does not affect any other analysers that interface with the versacell system.
Action
Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017.