Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Reason
Non-ce marked mersilene tape product codes are being supplied with a non-ce marked mersilene suture ifu., mersilene tape and mersilene suture have different indications. mersilene tape is primarily intended for use in, circular suture of the cervix.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Reason
Manufacturer has received and confirmed a report of a fire within the stainer module of a customer's dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module's methanol bath. beckman coulter is initiating this corective action to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Smith & Nephew Ltd, Unit A, 36 Hillside Rd, Wairau Walley, Auckland 0627
Reason
Manufacturer has identified the packaging to be insufficient to prevent a potential sterile barier break (pin hole) in the tyvek film of the pouch.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Some of the lids of one particular lot of atec canisters may have cracks and therefore this specific lot number is being recalled, the issue will be discovered during the inspection of the canister during the setup or via a system vacuum error when testing the eviva or atec biopsy needle. this issue does not pose any potential patient harm or other safety issue. however, it may prevent the system from enabling a procedure to continue.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The production process used to package the affected lots of herculite ultra, herculite xrv, point 4, and premise may lead to the presence of plastic particulates in the dental composite material.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The production process used to package the affected lots of herculite ultra, herculite xrv, point 4, and premise may lead to the presence of plastic particulates in the dental composite material.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Internal testing and investigative activities have confirmed that the the conductive ink which is necessary for the activation of the handset function did not meet predetermined durability requirements., manufacturer to perform a replacement of handset for the maxi move floor lifts affected by this issue.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
Reason
Reports have been received of issues that manifest themselves as power or communications failures in the system network. terumo's investigation revealed an internal cable with an inadequate crimp was installed in a subset of the total population of terumo system 1 units. the poor crimp in the cable can create a loss or degradation of internal power on one side of the system's base.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The flocare infinity enteral feeding pump 'air in line' (ail) alarm functionality may not always work with mixed or reconstituted powdered nutrition. un-dissolved particles may accumulate in the enteral feeding line or form a film on the inner side of the tube, around the pump sensors, which may interfere with pump air detection algorithms.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Smith & Nephew Ltd, Unit A, 36 Hillside Rd, Wairau Walley, Auckland 0627
Reason
The manufacturer has identified seal integrity failures on the folded sterile renasys™ transparent film pouches during transit testing. all the seal integrity failures identified during the testing occurred at the point where the sterile renasys™ transparent film pouches were folded during the packaging process.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
There have been a small number of occurrences (<0.1%) where an internal electrical fault has led to ventilation ceasing without either of the low battery alarms being activated. in all of these cases the total power failure alarm is activated as intended. this fault has also been reported with the astral external battery, however there have been no reports of cessation of ventilation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
There have been a small number of occurrences (<0.1%) where an internal electrical fault has led to ventilation ceasing without either of the low battery alarms being activated. in all of these cases the total power failure alarm is activated as intended. this fault has also been reported with the astral external battery, however there have been no reports of cessation of ventilation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Under rare circumstances there is potential for a sample id mismatch where the host computer(hc) connected to the instrument sends measurement order irregularly out from hc interface design specification.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Reason
Due to supplier moulding defect in the drip chamber prior to use and during prep, when contrast is drawn out of the contrast bottle air may be drawn into the contrast fluid channel from the vent channel resulting in the contrast having excessive air bubbles which can cause the burette to empty quickly and the blue ball to drop to the bottom of the chamber interfering with the contrast administration.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
The manufacturer is informing customers about a new bundled software update that will address multiple issues including issues that have already been previously communicated:, 1. prevention of automatic movements in case of significant risk for collision, 2.Re postioning of 160 mlc after motion stop interlock, 3.Restart of control console, 4. support of tractional monitor units for virtual wedge, 5. transfer of user-defined attributes from one session to another, 6. correction of wrong offset calculation in combination with images acquired with ctvision and also with adaptive targeting option, 7. correction of interrupt of cone beam reconstruction, 8. table rotation values for relative setup, 9. correction of wrong in-session resumption in case of 0 (zero) delivered monitor units, 10. unexpected table movement after internal error message on syngo rt therapist, 11.Update of user documentation "physics primer"., 12.Update of addendum for syngo rt therapist and user documentatio.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
An update of the syngo rt oncologisttm software is provided. the following safey issues have been addressed:, 1. incorrect automatic offset calculation in combination with images acquired with ctvisiontm, 2. incorrect offset calculation in adaptive targeting option, 3. problems with structure name in case of using structure operation functionality in segmentation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
New software update that addresses multiple issues including an issue communicated earlier:, 1. incorrect isocenter assignment when using multiple treatment plans with different isocenters based on one single planning ct and when a cbct has been acquired for each isocenter, 2.When auto field-sequencing (afs) is selected the pause is no longer present when treating a plan containing at least two beams with different isocentric table angles, 3. table movement due to different isocenters in imaging beams and treatment beams, 4. reference image has been associated to the wrong patient, 5.Incorrect calculated isocenter shift when using late resumption after interruption after beam 1 has been completed, 6.Multiple isocenter in session resumption f1 abort workflow is incorrect, 7. irrevocable assignment of the first reference 2d image, 8. after reverting plan changes in ois mosaiq changes performed on rt therapisttm become inactive.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Auckland District Health Board (Health Alliance), CDC Dept Level 4 Health Alliance Building, Auckland City Hospital, Park Road, Grafton, Auckland
Reason
Recall of specified implant kits (pumps) whichmay be more susceptible to electrical faults if the driveline becomes contaminated., contaimination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline., manufacturer has implemented manufacturing process improvements designed to prevent drivelne connector contamination in new implant kits.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
In a specific workflow where contours are edited (enlarged, moved, copied etc;) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner., if the patient is not saved and recalled, in a subsequently created plan the bev will show the contours as still present while the transverse, sagittal and coronal views will show the contours as deleted., if the user bases their clinical devisions on incorrect contours it could lead to dose erors and potential patient mistreatments.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
Reason
The unit is composed of two parts: (1) a detachable wall plug; and (2) the power adapter itself, with cord attached., there are three versions of the wall plug. only one is affected. in rare cases, one version of the detachable wall plug supplied with the medela breastpump could split exposing a live wire and creating a risk of electrick shock.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
Reason
Manufacturer has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality. symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. in one report, the ccm emitted smoke. although the occurrence for a ccm malfunction is unlikely, the possible risks of malfunction range from negligible to very severe.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Peruvian data is current through August 2018. All of the data comes from Digemid, 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 Peru.
Extra notes in the data
Reason
It does not have a sanitary registration in force.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Reason
There is a possibility of specimen misidentification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
In an unlikely set of circumstances, there is a potential for the first and/or last name of one patient to be printed with patient id and result data from a different patient, even though those fields have been turned off on the system. the patient id and patient test result data, however, are correct on the analyser screen and the lis. only the printout may contain the incorrect first or last name data, which should not have been printed because those fields were turned off in setup.