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.
In february 2016, siemens healthcare diagnostics issued field corrective action letter vc 16-01, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. at that time, preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. they have since confirmed complaints on additional vista bun flex cartridge lots, suggesting an additional cause of reduced gldh activity.
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.
An issue has been found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for roi plan dose statistics in the report may show the statistics for a beam set dose. the error can only be triggered when using a report template where statistics for a beam set dose are included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected., the user must be aware of information to avoid incorrect assessment of treatment plan dose levels. i.E inspect all report templates that are intended to be used for plans with multiple beam sets. make sure that "poi dose statistics (plan)" is included immediately before "roi dose statistics [plan dose]" in the report content area., this issue will be resolved in the next version of raystation, scheduled for market release nov 2016.
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.
Notes supplémentaires dans les données
Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
Cause
Thermogard dual dispersive electrode pads are not compatible with some brands of electrosurgical generators using passive cqm (contact quality monitoring) systems.
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.
Some units of the target nano detachable coils do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacture which can lead to an increased occurrence of coil stretching. note that this issue relates to the target nano range of detachable coils only.
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.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
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.
Notes supplémentaires dans les données
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Cause
Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified., alt and glucose-stat are ivd products designed for the quantitative determination of alanine aminotransferase (alt) or glucose on the beckman coulter au series of analysers., there is a possibility that drug interferences from administration of sulfasalazine to patients may generate false low (alt) results and false low glucose-stat results ., sulfapyridine may generate false high glucose-stat results.
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.
Notes supplémentaires dans les données
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Cause
Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified., alt and glucose-stat are ivd products designed for the quantitative determination of alanine aminotransferase (alt) or glucose on the beckman coulter au series of analysers., there is a possibility that drug interferences from administration of sulfasalazine to patients may generate false low (alt) results and false low glucose-stat results ., sulfapyridine may generate false high glucose-stat results.
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.
Notes supplémentaires dans les données
Recalling Organisation: Sirona Dental Systems Ltd, Unit 21, 14-22 Tritoin Drive, Albany, North Shore, AUCKLAND
Cause
Safety concern resulting from dac universal mk111 units that have been repaired using spare parts intended for mk11 units., the units possibly at risk are those that:, 1. fall within a determined serial number range and,, 2. where screws for the lid holder originally designed for the mk11 may have been used for a mk111 unit.
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.
Notes supplémentaires dans les données
Recalling Organisation: W M Bamford & Co Ltd, 12 Victoria Street, LOWER HUTT
Cause
Recall of product due to possible contamination with the metal needles in metalline products. the needles are from the needling process during manufacturing of the backfacing nonwoven, which are usually detected by a metal detector and separated.
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.
Notes supplémentaires dans les données
Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
Cause
In february 16, 2016 it was discovered that the ifu for the statlock sheath stabilization device was incorrectly packaged with the mega and sensation plus iab.
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.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
Ge healthcare has recently become aware of a potential safety issue with the patient bore heating on the discovery mr750w. a small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
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.
Notes supplémentaires dans les données
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Cause
During a non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan., the manufacturer has released a revised letter( 26/08/2016) which includes further detail specific to software version to the problem description, how to identify affected products, and advice on actions for customer clarity.
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.
Notes supplémentaires dans les données
Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
Cause
When the babytherm is operated in skin temperature mode with skin temperature sensor, but without a patient, the automatic controls monitoring skin temperature are not activated and the radiant warmer operates continuously at a high output level. during this forced continuous operation underder high thermal load, the heating element ages faster.
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.
Kits have been labelled with an incorrect year in the expiration date. the expiry date on calibration tubes within the kit are correct, but may be difficult to read on a portion of the tubes.
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.
Dimension / dimension vista creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr). the limit of quantitation (loq) claim (442 µmol/l) for urine samples is not met. this issue also affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.
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.
In treatment chart window while selecting the plan-of-the-day iq script to run, the treatment plan could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another treatment plan.
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.
During steam sterilisation validation the trident constrained liner impactor tips do not meet the required sterility assurance level (sal) of 10-6. these instruments are sterilised at the hospital prior to surgery and are not distributed as sterile.
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.
Notes supplémentaires dans les données
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Cause
Specific lots manufactured post june 2015 of the access free t3 reagent demonstrate an upward shift in patient results., patient sample results will shift upward by approximately 10.4% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change., additional assay performance characteristics are not affected., due to matrix differences, qc values may not demonstrate a shift.
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.
There is a possibility that one section of the outer package tyvek seal for the achillon® suture system may not remain completely sealed if not used within its shelf-life. the labeled product shelf-life is 5 years.
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.
Notes supplémentaires dans les données
Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
Cause
The manufacturer has updated the airvo 2 / myairvo 2 user instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.
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.
Notes supplémentaires dans les données
Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
Cause
The cortex screw was manufactured out of specification with a screw head recess that is too deep, which may lead to the screw head loosening from the shaft of a depuy synthes cortex screw during removal.
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.
V-pro® 1, v-pro® 1 plus, and v-pro® max sterilizers manufactured after january 1, 2014 may not display the correct date as of february 29, 2016. although the units display an incorrect date, the sterilizer functions and cycle operations continue to operate properly therefore safety and effectiveness is not impacted by the incorrect system date.
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.
Notes supplémentaires dans les données
Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
Cause
The guide sleeves (part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the tfna aiming arm properly.
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 precipitating hydrophobic injectable liquid (phil) container (syringe) may elute unintended elements (metals) into phil device formulation. the elution may or may not discolour the phil device.