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 identified an increased level of antibody of undetermined specificity (aus) when using some reagents of the id-system intended for irregular antibody screening and identification: id-cards for indirect antiglobulin testing (iat) associated to reagent red blood cells.
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.
Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
Causa
The manufacturer has found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector.
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.
Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
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.
Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
Causa
Post market surveillance has shown that some users have concerns about the method used by jaundice meters jm-103 and/or jm-105 to indicate that a taken measurement is out of range. as described in the instructions for use manual and in the device's training materials:, jaundice meter model jm-103 displays a blinking "- - -" when the measurement is out of range. the measuring range is defined to 340 µmol/l., jaundice meter model jm-105 displays a blinking "- 0 -" when the measurement is out of range. the measuring range is defined to 340 µmol/l.
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 describing an issue with the syringe plunger on the cobas e 801 module prewash syringe assembly. investigations determined that the issue may also occur on the cobas e 801 module r1 or r2 reagent assembly. depending on the affected syringe, r1, r2 or prewash, liquids may not be pipetted correctly due to the syringe plunger being damaged. depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. during the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function.
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.
There is a possibility that the cv-50 power supply board may become damaged if a fluid leak from the xn traveled down to the power supply unit of the cv-50. this could cause a short-circuit on the elements of the power supply board which may result in burning of the pcb board.
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: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
Causa
As part of a planned series of updates that began in 2017 with the release of merlin@home v8.2.2 software in april 2017, and continued with updates announced in august 2017 (cybersecurity update for low voltage devices), the manufacturer is planning to proceed with further firmware and software updates for certain icds/crt-ds (high voltage) intended to:, 1. improve cybersecurity protection., 2. incorporate the battery performance alert (bpa) for device-based detection of abnormal battery performance.
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 that the fixation of the upper and lower tilt actuator of the md-eleva system might break off and the table will start to rotate from 0 to + 90 / - 90 degrees with high speed if the point of gravity of the table is beyond its rotation point. this rotating movement can not be stopped by the user, which potentially could lead to the patient falling off the table.
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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
Causa
The manufacturer has indentified that the hudson rci one-way valve with capped may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.
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
In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded.
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.
Manufacturer has identified that all prismaflex control units exhibit a failure mode with the pump module electronics. the failure mode may result in a voltage out of range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. manufacturer will be releasing new firmware that will prevent the malfunction from occurring.
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
A performance issue with customer owned spare parts, t2100 microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction in 2015., if a spare part drive does not have the fmi correction label attached and is ge part number (2026182-002 or 2026182-004), or abb part number (fmh2a09tr-en43eq, fmh2a09tr-en43e, fmh2a09tr-en43e/12 or fmh2a09tr-en43gz), the firmware on the drive was not updated and spare part drive has not been corrected.
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
The manufacturer has identified that the system side of the power cord for certain vivid and logiq ultrasound systems may break and expose the electrical conductors leading to the risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest.
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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
There is a potential for improper welding of the yellow staple guide to the instrument. use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. this issue was identified during in-process quality testing at the manufacturing facility.
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 been informed of a number of reports of performance issues during the implementation of the elecsys vitamin d total ii assay on modular analytics e170, cobas e601 and cobas e 602 systems, as well as rare cases on cobas e 411 and cobas e 801., the issue manifests as: the first result is elevated, either above the upper end of the measuring range (>250 nmol/l) or within the measuring range; and repeats are significantly lower.
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 been informed of a number of reports of performance issues during the implementation of the elecsys vitamin d total ii assay on modular analytics e170, cobas e601 and cobas e 602 systems, as well as rare cases on cobas e 411 and cobas e 801., the issue manifests as: the first result is elevated, either above the upper end of the measuring range (>250 nmol/l) or within the measuring range; and repeats are significantly lower.
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 identified that the internal mains does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0.
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.
It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware 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.
It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware 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.
It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware 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.
It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware 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.
The manufacturer has confirmed dimension gentamicin (gent) lot bb8159 may exhibit inaccuracy for quality control (qc) and patient samples at the low end of the analytical measurement range. maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/l [1.94 µmol/l] and 1.9 mg/l [4.1 µmol/l], respectively. patient samples at 2.6 mg/l [5.62 µmol/l] did not show a bias. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators.