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.
Ortho-clinical diagnostics, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® 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.
Ortho-clinical diagnostics, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® 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.
Ortho-clinical diagnostics, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® 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.
Ortho-clinical diagnostics, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® 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.
Ortho-clinical diagnostics, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Causa
Complaints related to optical degradation have increased on the lh 750 and lh 780 hematology systems. users have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.
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.
Leica microsystems (schweiz) ag has discovered that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button., run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45°, 135°, 225°, or 315°. in addition, the run-on will stop if any other activation of the xy occurs.
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 become aware that friction within certain instrument arms can interrupt smooth instrument motion. this interruption is felt by by the surgeon as resistance in the movement of the master. in this situation the instrument can stall momentarily and then suddenly catch-up to the master psition id the surgeon pushes through the resistance. this resistance is most noticeable when moving the instruments at very slow speeds and during small movements of the masters. this system behaviour is not autonomous instrument motion.
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 complaints of damage to the thunderbeat hand instruments during surgical procedures. these complaints involve the following:, cracking and deforming of the thunderbeat probe tip/ jaw, partial separation of the ptfe (teflon) pad, exposed metal part due to severe wear of the ptfe pad.
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 a customer report of the cartridge injection counts not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 hemoglobin testing 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: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
Causa
The manufacturer has advised there are 2 issues with the system:, 1/ potentail for end cover of the column to dislodge if caught on an interfering object whilst the column is descending, 2/ potential communication issue that allows the user to make an exposure without capturing an image.
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.
Ocd investigations have determined that some vitros® mixing cup arrays may be out of specifications thereby causing an increase in sample metering dilution errors (eae condition codes) when using vitros 250 or 350 chemistry 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.
Notas adicionales en la data
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Causa
Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:, * flow cell clogs (: : ::), * ls offset errors during daily check or control analysis, * high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters, * system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs).
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
Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:, * flow cell clogs (: : ::), * ls offset errors during daily check or control analysis, * high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters, * system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs).
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.
When computing the effective depth (with bolus) to the weight point, xio could use the bolus density for a particular segment of the weight fan when it should be using the ct density. if the ct density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose., a resolution for this problem will be available in patch release 4.80.03 and release 5.00.01.
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
Complaints related to optical degradation have increased on the lh 750 and lh 780 hematology systems. users have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.
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
Complaints related to optical degradation have increased on the lh 750 and lh 780 hematology systems. users have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.
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.
Notas adicionales en la data
Causa
It does not have a sanitary registration in force.
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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
Causa
Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/l. the antigen excess capacity of this product has been reviewed and has been confirmed as correct. investigations have suggested that the tested sample contained predominantly monoclonal igm and the manufacturer believes that this particular type of igm reacted aberrantly with the antibody and subsequently yielded the spurious result.
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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
Oxygen and air wall or tank inlet fittings on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen gas concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate in the affected units. this only impacts ge resuscitation systems with blender.
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 xray volume imaging system (xvi) can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently., if patient and treatment table movements are not monitored ,and the automatic setup buttons are kept pressed ,the treatment table continues to move. it only stops when a touchguard activates. therefore this error can cause a collision between the patient and an external beam limiting device. if this error occurs with an external beam limiting device attached to the digital accelerator, it may cause fatal injury 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.
Notas adicionales en la data
Recalling Organisation: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
Causa
The manufacturer advises that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable., nova biomedical is recalling statstrip/statsensor batteries that do not have expiration dates printed on them that help to ensure the batteries are not used beyond their intended useful 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that your system has not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension; however, missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
Causa
A software anomaly has been identified with the plan parameters workspace within eclipse™ treatment planning system, aria®, and acuity. when a dose relevant parameter is changed and "do not clear mus and reference point dose" is selected, the monitor units (mus) may change without the user being aware of the changes.
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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
Causa
A software anomaly has been identified with the plan parameters workspace within eclipse™ treatment planning system, aria®, and acuity. when a dose relevant parameter is changed and "do not clear mus and reference point dose" is selected, the monitor units (mus) may change without the user being aware of the changes.