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.
Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm. if the ct data contain slices that occur at positions of xx.X50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimization and calculation of dose.
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.
Notas adicionales en la data
Recalling Organisation: Roche Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
Causa
Following customer complaints, internal investigations have confirmed under recovery of qc and patient samples with homocysteine reagent cat no05385415190 lot no 173114 by approximately 10-15% after 7 days exposure to 25oc. correctly stored reagent may show low recovery after 3-4 months.
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.
Notas adicionales en la data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
For artis systems with software version vc21c, vd11, and megalix cat+ x-ray tubes, the semi-automatic focus switch may in cases of a special type of defect in foci small and micro (if present), not work as intended when pressing the footswitch multiple times. this special type of focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.
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.
Notas adicionales en la data
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Causa
A complaint was received indicating that the non-gated bolus tracking clinical scan failed to initialize with the system displaying the error message: a problem has occurred; please retry. if the problem persists contact service.
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.
During internal investigation, it was identified that biomet orthopaedics cannot guarantee that the sterilization process for the optipac is fully compliant.
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.
Notas adicionales en la data
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Causa
Following update from fda regarding heater cooler units maufactured pre sept 2014 medsafe has asked obex to respond to nz market.
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.
Notas adicionales en la data
Recalling Organisation: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
Causa
The on/off functionality in the lcsu 4 is controlled by electronic components. one of these components might be damaged. the damage occurs over time when the unit is connected to a power source (battery or external power source), but is not related to frequency of use.
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.
Notas adicionales en la data
Recalling Organisation: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
Causa
Clamp screws used for the three affected units may in unusual circumstances break. these clamp screws are used to tighten both sides of brake clamps. when users receive the effected units, these screws could have been broken apart and could result in brake clamp dropping.
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.
Barb connector (stem) of the adapter may break when exposed to stress. the manufacturer has issued additional instructions for handling the peg y-adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector.
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.
Notas adicionales en la data
Recalling Organisation: MacoPharma Australia Pty Ltd, BDO Auckland, L8, 120 Albert St, Auckland 1010
Causa
The manufacturer was informed of a number of fast filtrations on the reference npt6280la. this has caused an absence of effective filtration through the media of the lcrd2 filter. this defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress.
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 manufacturer, has identified a manufacturing fault with this specific lot of the ez-tip product that could result in the device failing to perform its intended purpose.
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.
Notas adicionales en la data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
The manufacturer has determined that there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type. this can occur when an order is received from the lis without a sample type, requiring that the sample type be set in centralink based on the sample type of the test in the order.
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.
Notas adicionales en la data
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Causa
Without preventive maintenance, and/or periodic battery replacement, ups devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. all lead/acid battery-based ups devices are susceptible to 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.
Notas adicionales en la data
Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
Causa
Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers of corrosion being evident on screws as they are removed from the immediate packaging.
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.
Notas adicionales en la data
Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
Causa
Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers of corrosion being evident on screws as they are removed from the immediate packaging.
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.
Notas adicionales en la data
Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
Causa
Investigations have confirmed that the current published disinfection procedure of the hu 35 system's water paths (in the instructions for use) does not adequately meet contemporary hygienic requirements and effectiveness against atypical mycobacteria.
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.
Manufacturer has identified a lot specific stability issue with both reagent lots 10533up00 and 10534up00. as the reagent ages, relative light unit (rlu) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges.
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.
Notas adicionales en la data
Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
Causa
Atrium chest drains manufactured after october 18, 2016 will contain a new warning label that identifies the pouch as not being a sterile barrier and warns the user that only the chest drain can be entered into the sterile field.
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.
Notas adicionales en la data
Recalling Organisation: Bausch & Lomb (NZ) Ltd, c/o Bell Gully, Auckland Vero Centre, 48 Shortland Street, AUCKLAND 1140
Causa
An internal investigation, found that the operating instructions for several of these devices were either missing or obsolete.
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.
Manufacturer has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells., an extensive investigation identified microbial contamination as the root cause for the marked hemolysis.
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 manufacturer has recently become aware that some statlock™ catheter stabilisation device single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
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.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
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.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
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.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
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.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.