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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
Causa
The affected procedure packs include a bd 50ml luer lok syringe which is currently subject to a recall action. (ref #14513), the syringes have been manufactured with a new design stopper which may exhibit higher plunger forces and result in false occlusion alarms being triggered.
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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
Causa
The affected procedure packs include a bd 50ml luer lok syringe which is currently subject to a recall action. (ref #14513), the syringes have been manufactured with a new design stopper which may exhibit higher plunger forces and result in false occlusion alarms being triggered.
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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
Causa
The affected procedure packs include a bd 50ml luer lok syringe which is currently subject to a recall action. (ref #14513), the syringes have been manufactured with a new design stopper which may exhibit higher plunger forces and result in false occlusion alarms being triggered.
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
There is the potential for the vial volume of “in use” vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded.
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 hydrogen peroxide sterilization testing of the mia16 device it was determined that the sterrad 100s is not capable of achieving the expected sterility assurance level (sal) of 10-6. since the mia25t is longer and has a smaller lumen than the mia16, the mia25t is also affected. therefore, sterrad 100s should not be used on the mia16 or mia25t attachment.
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 hydrogen peroxide sterilization testing of the mia16 device it was determined that the sterrad 100s is not capable of achieving the expected sterility assurance level (sal) of 10-6. since the mia25t is longer and has a smaller lumen than the mia16, the mia25t is also affected. therefore, sterrad 100s should not be used on the mia16 or mia25t attachment.
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 potential for some units of the monopolar curved scissors (mcs) to develop very small cracks.("micro-cracks") near the distal (scissor) end. this may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. there is alos a risk that procedure time may be increased if the device needs to be replaced during surgery.
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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
Potential for incomplete staple line formation from reload damage during the firing sequence. this may result in insufficent tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.
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
The stated tolerance for ctdivol in the instructions for use manual did not accurately represent all systems. on some systems the measured ctdivol value may fall outside of these stated tolerances.
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
The stated tolerance for ctdivol in the instructions for use manual did not accurately represent all systems. on some systems the measured ctdivol value may fall outside of these stated tolerances.
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
The stated tolerance for ctdivol in the instructions for use manual did not accurately represent all systems. on some systems the measured ctdivol value may fall outside of these stated tolerances.
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.
A technical investigation has indicated that cartridges of this lot of oxoid antimicrobial susceptibility testing disc cvn30 (cefovecin), may contain discs with insufficient amount of antibiotic. continued use of this lot could result in false indication of resistance to cefovecin.
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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
There is potential for a loose connection between the wire and straight needle, which may impact conductivity and functionality of the device.
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: AMO Australia Pty Limited (NZ), c/- Exel New Zealand Limited, 3 - 5 Westfield Place, Mt Wellington, Auckland
Causa
There is potential for the laser to be fired inadvertently.
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.
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: Technisonic Systems 2013 Ltd, 2B Target Court, Wairau Valley, Glenfield, Auckland 6027
Causa
Due to a latent design reliability issue there is potential for electrical shorting which can result in heating/melting of the cable jacket.
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.
Stryker has received several reports that the irrigation pump was not functioning. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up potentially resulting in tissue burns to the patient.
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.
Patients can be scanned either head first or feet first and these cts imported into monaco for radiation treatment planning. the monaco ct sim workflow gives an option to prepare a feet first plan, but monaco imrt workflow does not. although a patient can be scanned feet first and these feet first cts imported into monaco, the user could incorrectly assume that the intensity-modulated radiation therapy (imrt) plan is feet first as well. when the patient is treated, they could be incorrectly positioned in the feet first position which will not match the plan. if the patient is positioned for treatment in the feet first position, the imrt treatment plan will not match what is delivered, potentially resulting in a significant beam geometry error.
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
If the film mode for image acquisition is not correctly calibrated it may result in overdose to patients.
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 is potential for users to have installed the incorrect build version of software (refer #11342) which did not include all the required software fixes to addressissues with image registration.
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
The manufacturer has identified an increased occurrence of stepper motor stalls with selected models of alaris gp infusion pump. it has been determined that these stalls are due to the stepper motor's front and rear bearings which may not perform as designed after a period of use causing the pump to stop infusing.
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 specific conditions inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed., this issue might lead to a wrong result released to the host if all the 3, following conditions are met:, 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation and,, 2. this negative result is consistent with the global interpretation of the test and,, 3. the system is configured without the second reading function activated for all tests results.
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: Des N Barnes, 313 Ararimu Road, Ramarama, Auckland 1750
Causa
Risk of patient misdiagnosis, inappropriate treatment or treatment delay due to incompatibility of software with certain protocols or ct units., analysis of data in vitrea ct brain perfusion 2d may lead to inaccurate perfusion maps if the data is acquired by an unsupported ct scanner.
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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Causa
Undiluted patient samples masured with the amh gen ii elisa kit may generate results that are lower than expected, due to interference from complement. this may lead to test results for neat amh patients samples being lower than expected.
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: W M Bamford & Co Ltd, 12 Victoria Street, LOWER HUTT
Causa
The manufacturer, mesa, recently determined that the read out time is not in specification with the label claims on these lots. there is potential for delayed or incomplete colour change (false fail) at the indicated incubation time of 10 hours.