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.
Notes supplémentaires dans les données
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Cause
The manufacturer confirms the advia centaur hiv 1/o/2 (ehiv) assay is not meeting its on-board stability claims of 28 days as stated in the ifu. customers are asked to reduce the on-board stability of their ehiv assay reagents to 14 days and to reduce the calibration interval of their ehiv assay reagents to 7 days.
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 agility beam limiting device (bld) does not support the use of apex at this time., apex has not been integrated or classified as compatible for use with the agility.
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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer had identified an issue relating to battery electrical short in devices which could have resulted in loss of communication with the device or the inability to recharge. when one of the battery terminals of the internal device battery came into contact with the circuit board, a short to the internal device battery could occur which may cause the ipg to not communicate or recharge, resulting in an explant.
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.
Notes supplémentaires dans les données
Recalling Organisation: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
Cause
The manufacturer advises there is potential for foil degradation on the dgp-hp rfa high-power single use grounding pads. this foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site.
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.
Notes supplémentaires dans les données
Recalling Organisation: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
Cause
The manufacturer advises there is potential for foil degradation on the dgp-hp rfa high-power single use grounding pads. this foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site.
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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer has become aware that some of their tme heart wires with zig zag fixation had an out of tolerance spacing between the anchoring zig zag and the end of the insulation. this additional spacing might cause difficulties when fixating the wire particularly in smaller hearts.
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.
Notes supplémentaires dans les données
Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
Cause
It was reported that the monitor did not display numeric values for sat levels or pulse rates in the spo2 parameter box screen, but there was a waveform present.
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.
Notes supplémentaires dans les données
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Cause
The manufacturer advises that the analytical sensitivity values greater than 0.3 mlu/ml described in the instructions for use (ifu) when evaluating multiple lots of the advia centaur fsh assay and calibrator b on the advia centaur and advia centaur xp 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.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
The manufacturer had advised that there are several potential issues with the dash 3000/4000/5000 patient monitors;, 1/ dash stops communication on the unity network resulting in loss of monitoring at the centra station, 2/ dash displays distorted ecg waveform in combination monitoring mode, 3/ dash incorrectly becomes time master on the unity network, 4/ dash date reverts to 1993, 5/ dashport 2 stops communicating on the unity network resulting in loss of monitoring at the central station.
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.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
The manufacturer had advised that there are several potential issues with the dash 3000/4000/5000 patient monitors;, 1/ dash stops communication on the unity network resulting in loss of monitoring at the centra station, 2/ dash displays distorted ecg waveform in combination monitoring mode, 3/ dash incorrectly becomes time master on the unity network, 4/ dash date reverts to 1993, 5/ dashport 2 stops communicating on the unity network resulting in loss of monitoring at the central station.
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.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
The manufacturer advises there are several potential issues with this device;, 1/ the b850 may enter into a constant reboot loop causing the monitor to reboot continuously., 2/ an insecurely connected or faulty usb cable may cause the monitor to reboot., 3/ there may be printing delays with the prn50 printer, 4/ the device may reboot due to an x server freeze.
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.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
The manufacturer advises there are several potential issues with this device;, 1/ the spo2 saturation limit alartm does not always active with the nellcor spo2, 2/ the device may enter into a constant reboot loop causing the monitor to reboot continuously., 3/ the device may reboot when connected to the unity id, 4/ the device may not update the software for power management card., 5/ an insecurely connected or faulty usb cable may cause the monitor to reboot., 6/ there may be printing delays with the prn50 printer, 7/ the device may reboot due to an x server freeze.
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.
Notes supplémentaires dans les données
Recalling Organisation: Lima Orthopaedics New Zealand Ltd, 20 Crummer Road, Grey Lynn, AUCKLAND 1021
Cause
Monitoring and analysis of the clinical results of the smr l2 metal back glenoid component indicate that under certain conditions, for example rotator cuff failure or patient trauma, the polyethylene insert can disassociate. the total revision rate of the l2 version of the smr metal back glenoid componet in australia is 6.78% at three years.
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.
Notes supplémentaires dans les données
Recalling Organisation: Surgico Medical & Sugical Ltd, Unit A, 3 Whetu Place, Rosedale, North Shore City, AUCKLAND 0632
Cause
There is a possibility that the iskd limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace 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.
Notes supplémentaires dans les données
Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Cause
The manufacturer has advised that the reason for the recall is that pinholes in a small number of pouches have been detected which constitutes a breach of the sterile barrier.
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.
Notes supplémentaires dans les données
Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Cause
The manufacturer has advised that the reason for the recall is that pinholes in a small number of pouches have been detected which constitutes a breach of the sterile barrier.
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.
Notes supplémentaires dans les données
Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Cause
The manufacturer has advised that the reason for the recall is that pinholes in a small number of pouches have been detected which constitutes a breach of the sterile barrier.
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.
Notes supplémentaires dans les données
Recalling Organisation: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
Cause
The manufacturer advises that the affected lot of cavitec may set slower than indicated in the directions for use. although an inconvenience, there are no safety or efficacy issues associated with cavitec as the product will eventually set.
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 advises that there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadraplegia, and the risk of a potentially life-threatening event.
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 advises that there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadraplegia, and the risk of a potentially life-threatening event.
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 advises that there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadraplegia, and the risk of a potentially life-threatening event.
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.
Notes supplémentaires dans les données
Recalling Organisation: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
Cause
The manufacturer has determined that some devices (approximately 0.1%) may exhibit difficulty inflating and/or deflating.
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.
Notes supplémentaires dans les données
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Cause
The manufacturer has determined that a small amount of residual cleaning solution may remain in the system fluidic lines following the monthly cleaning procedure (mcp) and the daily cleaning procedure (dcp). this may cause the following impacts to assays on some systems.
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.
Testing by the tga has determined general microbial counts exceeding the australian microbial standards for medicines (tgo77). such microbial levels consitute a moderate to serious health hazard for infection, expecially if the gel is used for a non-intended purpose, e.G. an invasive procedure.
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 determined that the sealed edge of the pouch may not have been uniformly formed and pleats or creases may have been formed which could have the potential to compromise the barrier integrity of the pouch.