Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
The manufacturer advises that under certain preconditions, executing roadmap ogp (organ program) in the dsa overlay mode may lead to imprecise registration of the dsa mask image with the roadmap image displayed on the live monitor.
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.
Stryker has become aware that for sources utilizing s-video and composite inputs, pal analogue video signals appear with jagged edges on all diagonal lines resulting in poor video quality.
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: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
Causa
Instructions for use contain the incorrect timing parameters for this product.
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.
Post fuse assemblies on certain modela of invacare power wheelchairs, which could potentially be defective in a manner that would result in the fuse not operating as intended (blowing) in the event of future damage or faults within the main wiring harness., while each battery is equipped with a fuse that alone would provide the intended safety function , there is a potential risk of fire and serious injury should both fuses be defective.
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.
Abbott point of care has removed the recommendation to use blood collection devices that are at least half (1/2) full from i-stat system user documentation. apoc recommends that samples are obtained from blood collection devices filled to their stated volume regardless of cartridge or sample type.
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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
Causa
Potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.
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: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
Causa
Aez mini distal custter labeled as long-handle cutters actually contain short-handle cutters.
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 reports of barcodes on reagent packs being unable to be scanned due to the barcodes being diffuse and/or having white spots within the barcode which prevents them from being read consistently by the m2000sp instrument.
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 the ct systems above, sixteen bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off., a risk of serious injury (bone fracture, head injury, concussion) was identified in the event that all sixteen (16) bolts are broken. if this occurs, and the carbon table top is extended, the table top may tilt or tip over, or it may result in unintended pivotal motion of the table. if the patient is not secured to the table, there is a possibility the patient may slide off, which may cause serious injury. if less than sixteen (16) of the j-bracket bolts fail, the carbon table top will remain attached to the couch subframe.
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 the ct systems above, sixteen bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off., a risk of serious injury (bone fracture, head injury, concussion) was identified in the event that all sixteen (16) bolts are broken. if this occurs, and the carbon table top is extended, the table top may tilt or tip over, or it may result in unintended pivotal motion of the table. if the patient is not secured to the table, there is a possibility the patient may slide off, which may cause serious injury. if less than sixteen (16) of the j-bracket bolts fail, the carbon table top will remain attached to the couch subframe.
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 the ct systems above, sixteen bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off., a risk of serious injury (bone fracture, head injury, concussion) was identified in the event that all sixteen (16) bolts are broken. if this occurs, and the carbon table top is extended, the table top may tilt or tip over, or it may result in unintended pivotal motion of the table. if the patient is not secured to the table, there is a possibility the patient may slide off, which may cause serious injury. if less than sixteen (16) of the j-bracket bolts fail, the carbon table top will remain attached to the couch subframe.
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
The manufacturer has received reports of certain size 8 shiley™ reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
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
The manufacturer has received reports of certain size 8 shiley™ reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
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: Ottobock Australia Pty, Suite 1.01 Century Corporate Centre, 62 Norwest Boulevarde, Baulkham Hills, NSW 2153, AUSTRALIA
Causa
The manufacturer received some complaints about adapters that show a crack starting at the clamping of the adapter into direction of the clamping slot. due to the crack, the clamping to the tube adapter is lost and the prosthesis twists when loaded. depending on the situation this may cause the patient to fall.
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 heartstart mrx defibrillator monitors are used in external transport and ems environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads cpr therapy cable and external paddles cable) and the mrx therapy connection port may experience higher than expected levels of stress causing accelerated wear. without routine periodic inspections and preventive action by users, wear of the connection could ultimately prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also may cause the mrx to inappropriately identify the pads therapy cable, external paddles, or internal paddles.
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.
Symantec informed roche in a security advisory about a defect in their product pcanywhere (version 12.6.6 and older), a software product for accessing pcs remotely. the defect is a so called "pre authentication vulnerability" which allows full access to the target system without having to log on.
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.
Symantec informed roche in a security advisory about a defect in their product pcanywhere (version 12.6.6 and older), a software product for accessing pcs remotely. the defect is a so called "pre authentication vulnerability" which allows full access to the target system without having to log on.
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.
Symantec informed roche in a security advisory about a defect in their product pcanywhere (version 12.6.6 and older), a software product for accessing pcs remotely. the defect is a so called "pre authentication vulnerability" which allows full access to the target system without having to log on.
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 use of the disposable general purpose 9 french temperature probe for nasopharyngeal applications can create, in certain clinical conditions, a potential for severe epistaxis (nose bleed), which may require interventional procedures or prescription medications to properly resolve.
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 advises that cs-2000i and cs-2100i with software version 00-60 show the phenomenon that certain results with error flags highlighted for review, are automatically validated and sent to the host computer without those flags.
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
Recall for a single lot of the sterrad 100s system cassettes. manufacturer has disccovered that printed information on the cassette results in the sterilizer being unable to properly read the barcode. during the automated process used to print information on sterrad 100s system cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette.
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.
Notas adicionales en la data
Recalling Organisation: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
Causa
Outer packaging of individual gowns may be compromised.
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: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
Causa
Outer packaging of individual gowns may be compromised.
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.
Radiometer medical has become aware that there is a potential risk of reporting of current patient results to a previous patient id. this may occur when an abl90flex analyzer with software versions below v2.7 mr4 is using the hl7 v2.5 communication protocol for transmitting results to a his/lis system.