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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
The manufacturer advises that ysio systems with fixed detectors in the wall stand may experience line artifacts in the image. should these artifacts appear in the region of interest, the examination may need to be repeated.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Reason
Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
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.
Extra notes in the data
Recalling Organisation: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
Reason
The manufacturer has received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. investigation of the retained and returned product confirmed that the composite does not extrude easily. additionally, any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.
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.
Extra notes in the data
Recalling Organisation: Auckland District Health Board (Health Alliance), CDC Dept Level 4 Health Alliance Building, Auckland City Hospital, Park Road, Grafton, Auckland
Reason
Batteries produced in these specified ranges are more likely to exhibit premature or unrecognized deterioration of battery capacity, which poses a risk to the patient since it may result in a pump stop.
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.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
This is a follow up letter to recall action issued in august 2014 to advise that the small sample container (ssc) can be used with the dimension vista® hemoglobin a1c (hba1c) assay with software version 3.6.2 or higher.
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.
Extra notes in the data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Reason
Manufacturer has identified an issue with patient demographic information sent to the lis from advia centar/ advia centaur xp immunoassay systems. under extremely rare circumstances patient demographic data from the previous order received from the lis is merged with the next order., this issue can occur when the lis data buffer on the advia centair system becomes full and a particluar character if doun dn the last locations in the lis data buffer.
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.
Extra notes in the data
Reason
Does not meet the requirements of good manufacturing practices (gmp).