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
The manufacturer is advising that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis-identification., this is an updated notification in follow-up to the previous communication received (dated 16 october 2017) concerning duplicate sample requests leading to sample mis-identification when using the aquios cl systems connected to a laboratory information system (lis). this important information needs immediate attention. the information replaces the instructions in the original notification dated 16 october 2017.
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: Lima Orthopaedics New Zealand Ltd, 20 Crummer Road, Grey Lynn, AUCKLAND 1021
Causa
The manufacturer has detected a defective welding by the supplier on all the broken instruments received. specifically, the absence of base material pre-fusion and under-dimensioned welding radius was identified.
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
There is potential packaging damage to have occurred during transportation, resulting in a loss of sterility. recent testing has identified certain shipping configurations which may cause damage to the sterile barrier pouch if the surgical punches experience excessive movement from multiple drops during transport.
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 (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
Causa
Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
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 (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
Causa
Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
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 (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
Causa
Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
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.
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 (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
Causa
Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
Causa
Even though hcu 20 and hcu 30 do not emit contaminated aerosols, the manufacturer developed and validated new safe and user-friendly water quality management procedures to be implemented on all hcu 20 and hcu 30 systems in the 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Causa
The manufacturer has identified that the label of heparin coated devices does not explicitly state that they are heparin coated. the products are labeled with the correct catalog identifier, which includes the suffix bh that indicates the product is heparin coated. however, users who are not familiar with the bh nomenclature may not be aware that the product contains heparin.
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 manufacturer has become aware of a potential problem with our philips brilliance 64/ ingenuity family version 4.1.6 as detailed below:, issue 1: cardiac signal not found in workflow issue, issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start, issue 3: pulmo gates on cardiac workflow issue, issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well., issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results, issue 6: application may fail when modifying the results plan box during 3d calcium score, issue 7: tube too hot, issue 8: memory overflow issue, issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message, issue 10: issue with the generatormonitor state machine in rhost code 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
The manufacturer is aware of a potential risk of unnecessary radiation exposure due to a software issue found in the care dose4d algorithm implemented in the siemens healthineers ct scanners.
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.
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.
Partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery 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.
Partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
Causa
From the manufacturer investigation it was concluded that the issue relates to a crack in the metal of the spring arms that has the potential to develop into a break. these paticular devices are over ten years old and even so the vast majority have not failed.
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
An internal investigation has identified that if the bleach cycle is interrupted or aborted, the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected.
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 this issue affects specific lots of arcticgel ™ pad kits. the affected units have the potential for there to be insufficient adhesion of the hydrogel to the pad. this can be easily identified if the hydrogel peels away with the release liner.
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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
Causa
An internal investigation has confirmed, occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc® 700327™ in association with three(3) vitek® 2 gp id, causing failure of the quality control (qc) testing for the vitek® 2 gp id card. in accordance with the vitek® 2 gp id instructions for use, the expected o129r reaction for atcc® 700327™ strain is positive. as a precaution, the manufacturer is also including in the scope of this notice all gp id card lots manufactured with the same raw materials.