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
The descriptor field of the file settings may become partially fragmented while in standby mode. this does not change the performance of the device and the rpm/speed or ratio displays remain as depicted in the instructions for use (ifu).
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 philips heartstart mrx monitor/defibrillator can deliver a non- synchronised shock in the synchronised cardioversion mode. this can occur if the user rotates the therapy knob while simultaneously pressing the sync button, then charges the mrx and presses the shock button., the mrx will still display r wave markers as if normally operating in synchronised cardioversion mode. the "sync" label will still be seen on the display. when the mrx is charged and the shock button pressed, the shock will be immediately delivered and may not be synchronised to the r wave., in addition, the label affixed to the top of the mrx device is not consistent with the mrx instructions for use on synchronised cardioversion.
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
Siemens biograph mct systems running vg40a or vg40b software could experience intermittent ct or pet/ct scans aborting during an examination, as well as intermittent ct planning and image reconstruction failures.
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 affected prolystica ultra concentrate alkaline detergents may not have the dangerous goods label attached to illustrate that the product is hazardous.
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
Following an incident at a medical centre in the united states a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 system. the cause of the incident is under investigation. users are recommended to ensure;, 1/ only qualified service personnel maintain the equipment, 2/ that preventative maintenance procedures are conducted according to the documented schedule, 3/ all users re-review the safety chapter sections of the system manual.
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.
Zimmer is recalling micro femurs, micro patellae and micro articular surfaces to prevent use of these components in combinations that are not approved by the manufacturer. devices will be available for revision surgeries only.
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.
Zimmer is recalling micro femurs, micro patellae and micro articular surfaces to prevent use of these components in combinations that are not approved by the manufacturer. devices will be available for revision surgeries only.
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.
Zimmer is recalling micro femurs, micro patellae and micro articular surfaces to prevent use of these components in combinations that are not approved by the manufacturer. devices will be available for revision surgeries only.
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.
Zimmer is recalling micro femurs, micro patellae and micro articular surfaces to prevent use of these components in combinations that are not approved by the manufacturer. devices will be available for revision surgeries only.
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.
Synthes received several complaints that the clamps could not be connected with the transpedicular schanz screw, because in some cases, the shaft of the screw is too thick.
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 antigen composition sheet supplied with the product listed cell 5 as lua negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 did in fact type as lua positive.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
Potential risk for helium gas inside the mr examination room during a magnet quench.
Acción
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
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 antigen composition sheet supplied with the product listed cell 5 as lua negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 did in fact type as lua positive.
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
Manufacturer has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a qc or calibrator from a vista vial. if two samples are dispensed into the same aliquot well, the first sample will always be qc or calibrator from a vista vial. patient sample will never be dispensed into an aliquot well that contains another patient sample.
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
Manufacturer is undertaking a hazard alert for the following 3 issues:, internal electrical shorting - an electrical short can occur when ions from the drug solution and humidity permeate through the drug patrhway tubing inside the pump and interact with the feedthough over time. this may present as a motor stall, or low battery reset/ alarm and leads to a loss or reduction in therapy., priming bolus - patients may receive unintended drug at a high rate of infusion in the csf during the priming bolus and a period of reduced concentration of drug wll occur following the priming bolus., pump refill - this is a re-issue and update of information sent to patient in dec 2010.
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
Manufacturer is undertaking a hazard alert for the following 3 issues:, internal electrical shorting - an electrical short can occur when ions from the drug solution and humidity permeate through the drug patrhway tubing inside the pump and interact with the feedthough over time. this may present as a motor stall, or low battery reset/ alarm and leads to a loss or reduction in therapy., priming bolus - patients may receive unintended drug at a high rate of infusion in the csf during the priming bolus and a period of reduced concentration of drug wll occur following the priming bolus., pump refill - this is a re-issue and update of information sent to patient in dec 2010.
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 identified that the percent recovery for 1:10 diluted patient sample dilutions is lower than reported in the instructions for use.
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.
Elekta is aware that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults., increasing auto-tracking values from factory-set defaults goes against elekta recommendations and can result in the system becoming non-compliant with iec standards, in particular with the safety standard iec 60601-2-1.
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
There is potential for the single pack pouch to be damaged leading the microcuvettes to not perform as intended if exposed to moisture.
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
Affected lots of insulin reservoirs have an increased risk of leaking. a leak in the reservoir may result in delivery of less insulin than intended and, if there is an occlusion in the infusion set, the pump may not alarm.
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.
Sample couch parameter files are supplied with monaco release 3.100 and later. the user can then access these files from the treatment couch library.By clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the "save as treatment couch" to enter a unique name for the modified couch parameter file., when sample couch parameter files are edited, the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, the modified couch densities in these samples will be overwrittem with the default value of 1.000.
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.
As issue has been identified in the raystaion 3.0 and 3.5 dose volume statistics calculation. under certain conditions resampling of regions of interest (roi) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each roi., the problem is pronounced for very small rois, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. worst-case scenario is delivering less dose than optimal to target organs.
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: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
Causa
Sponsor advises that the buchanan plugger .08 taper, which should have a .08 laser mark on the shaft of the plugger, actually has a .06 laser mark instead. although an inconvenience the product will functon as expected.There are no safety or efficacy issues associated with this laser-marking error.
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
Manufacturer has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the look-ahead view labels to show user selected depths (displayed) , but the corresponding images are shown at a depth twice the selected distance. under these conditions visulaization of the planned trajectory could show the image at the incorrect depth. further internal investigation discovered that the use of high resolution exams (256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay.