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.
Potential risk with pico arterial blood sampler where it has been reported that some needles have a brownish coating. the needle may not be sterile and if contaminated would expose the patient to a risk of developing a blood stream infection.
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: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
Causa
When a blade from an affected lot is fited to certain mac video laryngscopes it may be difficult to get the blade clip to engage onto the tooth on the handle. this increases the possibility of blade becoming disconnected during intubation specifically when the device is being retracted from the mouth of 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
Anatomical printouts may not be printed in correct anatomical size.
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
During efforts to restore performance of the androstenedione assay, manufacturer observed over-recovery in the immulite 2000/ immulite 2000xpi androstenedione for samples across the assays' reportable range of 0.3 - 10 ng/ml (1.1 - 35 nmol/l). manufacturer confirmed the issue noted in december 2013 (medsafe ref#15975) is not limited to samples >5.5ng/ml (>19.2 nmol/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.
Notas adicionales en la data
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
The proteus xr/a and revolution xr/d x-ray service manuals have been updated to further ensure proper re-installation. reinstallation errors may result in a fall of a collimator while the system is in use, resulting in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
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 proteus xr/a and revolution xr/d x-ray service manuals have been updated to further ensure proper re-installation. reinstallation errors may result in a fall of a collimator while the system is in use, resulting in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
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
Philips reports there are 2 issues to be addressed:, 1/ following a cardiac scan and when using smartstep* to setup the camera for a relative 180 procedure, it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed., 2/ during a patient spect lung acquisition, the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degree position. however, in the middle of a clinical scan acquisition, the detector heads moved away from the patient (center of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degree to the 240 degree may take approximately 7 seconds.
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
When using the qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller esv calculated by manual tracing without the use of qlab. correspondingly, the left ventricular ejection fraction (ef) calculated using these applications may be higher than the ef calculated by manual tracing without the use of qlab. philips' investigation has found that this difference may occur in cases where the ef is less than approximately 40%.
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.
Sunrise medical has issued a product notification following the return of 2 hoists model g175 due to the legs moving in an incorrect 'v' position., distributors and consumers are being notified of important new information relating to conditions of use and revised inspection criteria. the revised information covers conditions of use, daily checks, and ongoing maintenance requirements which will reduce possible damage to the hoist legs which in turn may affect the stability of the hoist.
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.
Halyard health's quality assurance processes have identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use (i.E., if pulled, tugged, or excess tube/patient movement occurs). detachment of the inflation line leads to gradual deflation of the endotracheal tube cuff potentially leading to respiratory circuit air leak between the cuff and tracheal wall.
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 gravity unwrapped sterilization cycle and the ethylene oxide sterilization cycle have been removed from the instructions for use, ifu1000-401-070, as a sterilization option for the laparoscopic manual instruments and accessories listed above.
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 gravity unwrapped sterilization cycle and the ethylene oxide sterilization cycle have been removed from the instructions for use, ifu1000-401-070, as a sterilization option for the laparoscopic manual instruments and accessories listed above.
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 gravity unwrapped sterilization cycle and the ethylene oxide sterilization cycle have been removed from the instructions for use, ifu1000-401-070, as a sterilization option for the laparoscopic manual instruments and accessories listed above.
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 gravity unwrapped sterilization cycle and the ethylene oxide sterilization cycle have been removed from the instructions for use, ifu1000-401-070, as a sterilization option for the laparoscopic manual instruments and accessories listed above.
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 gravity unwrapped sterilization cycle and the ethylene oxide sterilization cycle have been removed from the instructions for use, ifu1000-401-070, as a sterilization option for the laparoscopic manual instruments and accessories listed above.
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 Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
The leak indicator on the asp sterrad® system cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. sterrad® system cassette packaging assemblies are designed with a leak indicator on the inner package to provide a visual color indication in the event hydrogen peroxide has leaked from the cassettes.
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 is updating the instructions for use to include additional instructions and warnings when these devices are used for some gyneacological applications.
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 is updating the instructions for use to include additional instructions and warnings when these devices are used for some gyneacological applications.
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.
Teleflex are recalling specific products following receipt of customer complaints reporting that the cobb connector detached from the main connector prior to use. this cobb connector detachment should be readily identified by the user during set-up and prior to use of the device. if during use, cobb connector separation occurs and presents as a leak in the breathing circuit and if it is unnoticed, then there is a remote probability that the patient may need to be re-intubated due to the risk of respiratory distress and hypoxia.
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 received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a drx revolution mobile x-ray system as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. no other reports of this type have been received since the device was introduced into commercial distribution in 2009.
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.
This recall has been initiated due to a packaging defect that could potentially compromise the sterility of this device. use of a non-sterile device could potentially cause permanent impairment or life-threatening injury. no injuries or deaths have been reported.
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: N Stenning & Co NZ Limited, C/O Bellingham Wallace, 470 Parnell Road, Parnell, Auckland 1052
Causa
This recall has been initiated due to a packaging defect that could potentially compromise the sterility of this device. use of a non-sterile device could potentially cause permanent impairment or life-threatening injury. no injuries or deaths have been reported.
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.
The manufacturer is updating the user manuals, instructions for use (ifu), quick reference guides (qrg), the natural rubber latex qrg, and the instrument release kit. these changes are being made in response to 66 unique adverse event reports associated with use scenarios that were not previously addressed in these documents.
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 mrx could contain incorrect internal software settings, causing the following two issues:, 1. the device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended., 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead, the rfu will show a flashing black hourglass, indicating that sufficient battery power is available for device operation.