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.
Medical device correction iniitiated as a result of of customer complaints investigation for anothe product regarding calibration failure and late retention times associated with elution buffers. the company examined the potential for a similar problem with the above buffer lots. bio-rad requesting customers to discard all affected product.
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.
Medical device correction iniitiated as a result of of customer complaints investigation for anothe product regarding calibration failure and late retention times associated with elution buffers. the company examined the potential for a similar problem with the above buffer lots. bio-rad requesting customers to discard all affected product.
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, cincinnati sub-zero has made changes to the warmair@ model 135 convective warming devices operation & technical manual to stay in compliance with fda labelling regulations.
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 affected devices may experience unexpected power cycling (system reboot) during device power on (startup). some devices have been observed to experience rebooting cycles for up to five minutes before the mrx stabilizes. if the problem were to occur there is a potential that therapy may be delayed.
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.
Perkin elmer has become aware about lifecycle risk calculation problem that can potentially take place with assisted reproduction screening where an egg donor is involved. the change in calculated risk is dependent on the age difference between the mother and the egg donor. in the worst case, if the age of the mother is substantially higher than the egg donor's age. a true low risk value can be turned as high and thereby cause indirect harm because of possibility for an unnecessary medical intervention.
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 issued a recall for all lifts that have been in use for in excess of 10 years (recommended lifetime for the device) due to such devices failing in use and/or not being appropriately serviced and maintained.
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.
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 carabineer used to attach the spreader bar to the lifter, may show some wear in case of intensive/ severe use. this carabineer needs to be checked and replaced if the thickness of its sections measures less than 6 mm. a change to the carabeineer's shape has also been made to reduce the potential for disengagement of the spreader bar.
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: Lifehealthcare Ltd New Zealand, Unit E 61 Hugo Johnston Drive, Penrose, Auckland 1642
Causa
Fda notified physicians and patients about the risk of catheter entrapment associated with the use of onyx. catheter entrapment happens when the catheter becomes stuck in the implanted onyx material. the most serious complications include hemorrhage and death. other complications include migration of the onyx plug or catheter fragment to other parts of the body. patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and onyx plug, increasing their exposure to radiation.
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.
If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:, issue1: the coordinates will be in dicom space, thus not matching the setup reference dialog., issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.
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: AlphaXRT Ltd, 10 The Promenade, Takapuna, Auckland
Causa
If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:, issue1: the coordinates will be in dicom space, thus not matching the setup reference dialog., issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.
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
An fda review of asp data showed that the sterrad cyclesure 24 biological indicators cannot effectively monitor the sterilization process throughout the indicated 15-month shelf life. after reviewing additional asp data, the fda believes that the product may be used with a 6-month shelf life.
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: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Causa
The distal part of the anchor may break on insertion into bone 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Causa
Manufacturer has received 1 report of an empty needle pouch. customers of needles manufactured on the same day are advised of the potential for this to occur and to report/return any affected 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.
The manufacturer has received complaints of elevated results using heparin plasma samples for vitros chemistry products dgxn slides. as a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for vitros dgxn slides.
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.
Radiometer medical has become aware that there is a potential risk of reporting of current patient results to a previous patient id. this may occur when an abl90flex analyzer with software versions below v2.7 mr4 is using the hl7 v2.5 communication protocol for transmitting results to a his/lis system.
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: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
Causa
Outer packaging of individual gowns may be compromised.
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: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
Causa
Outer packaging of individual gowns may be compromised.
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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
Recall for a single lot of the sterrad 100s system cassettes. manufacturer has disccovered that printed information on the cassette results in the sterilizer being unable to properly read the barcode. during the automated process used to print information on sterrad 100s system cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette.
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 advises that cs-2000i and cs-2100i with software version 00-60 show the phenomenon that certain results with error flags highlighted for review, are automatically validated and sent to the host computer without those flags.