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
Manufacturer has discovered through customer complaints and internal testing that uncontrolled geometry movements can occur when the sytem is not switched on/off regularly. due t the nature of the proble the ser will perceive a gradually increased sluggishness. upon activation of the iu controls an uncontrolled geometry movement casn occur. the uncontroled movements are immediateky stipped upon release of the iu controls.
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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Causa
Manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, manufacturer concluded that the compromised balloon performance was caused by certain characteristics in the manufacturing process. biosensors positively identified production lots manufactured between october to december 2015 that could have been similarly affected., the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient's state of health during pci., patients who have already been implanted with an affected device are not impacted by this field safety corrective action. no field complaint or patient injury has been reported associated with the compromised balloon performance.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Causa
Manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, manufacturer concluded that the compromised balloon performance was caused by certain characteristics in the manufacturing process. biosensors positively identified production lots manufactured between october to december 2015 that could have been similarly affected., the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient's state of health during pci., patients who have already been implanted with an affected device are not impacted by this field safety corrective action. no field complaint or patient injury has been reported associated with the compromised balloon performance.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
Causa
Recall is being conducted due to the potential for the sterile barrier to be compromised at the package seal. the use of products with this condition may result in a potentially increased risk for infection.There have been no reports of serius injury associated with 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.
Notas adicionales en la data
Recalling Organisation: Smith Biomed (NZ) Ltd, P O Box 8108, Level 2, 44B Victoria Road, New Plymouth
Causa
Due to an issue with over labelling of the simtomax coeliac disease test the expiry dates may not correctly match the stock supplied. the efficacy of the test is not in question however stock received may not necessarily reflect the correct batch that should have been received. the tests are not past their expiry date and the tests that consumers have taken to date had not expired and the efficacy of the test is not in question.
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
Issue:, a) if the system language is set to english and the yyyymmdd date format is used, the patient's date of birth received through the dicom worklist and query/retrieve will be displayed with month and day reversed for patients who have birthdays on days 1 through 12. birth dates for days 13 through 31 are displayed correctly. the issue only appears to happen for days 1 through 12., b) system crash may occur during dvd live recording if radiation is released while the dvd icon on the flc status bar is blinking. in this case error messages will be displayed and a system reset is necessary., c) sporadically the system will not be ready for radiation during reconnection of the trolley to the main unit. a system reboot is necessary.
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 the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches end of shelf life.
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: Smith & Nephew Ltd, Unit A, 36 Hillside Rd, Wairau Walley, Auckland 0627
Causa
Manufacturer has identified a risk that some external power units have the potential to overheat and induce an electric shock whilst in use with the renasys™ go npwt pump.
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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Causa
The analysis of the customer complaint has identied an issue related to suctioning with the use of the hamilton-g5 and hamilton-s1 ventilators. after preforming the suctioning manuoeuvre, including disconnecting the patient suctioning and then reconnecting the patient the preset pattern of the ventilation may not continue as expected. this software flaw may lead to either hyperventilation or hypoventilation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
It was identified that the neuroform atlas pouch and carton label references the incorrect measurement in millimeters for the minimum catheter diameter. the minimum catheter diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. the correct conversion value is 0.42. the labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. the result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices.
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
They become aware of a potential problem with the philips brilliance ct and ingenuity ct. issues with v4.1.3 and v4.1.4 software: system may not automatically send all image data series to remote devises. the customer stated that intemittently some of the series images acquired on the brict system using v4.1.30906 software will not auto send a separate study series to the pacs9 picture archiving and communication system) while other series within the same exam card will auto send.
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.
Since the market launch of this product, the instruments were distributed with instruction for use related to the method for cleaning and disinfection and for steam sterilisation at health care facilities; however, the method was not adequately validated., instruments cleaned, disinfected, and sterilised under the former ifu for the uniwallis systems may not be adequately cleaned, disinfected and sterilised resulting in a risk of infection., manufacturer to provide updated cleaning disinfection and sterilisation instruction for use of uniwallis™ system.
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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
Causa
A technical investigation has confirmed that individual bottles of oxoid nitrocefin (+ reconstitution fluid), lot 1717357 may produce weak beta-lactamase reactions. not all of the lot is affected; however, continued use may result in delayed or false negative reporting.
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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
Causa
The alarm te63/64 is generated during some circumstances when the flow -i-anaesthesia systems considers that the internal communication does not work as intended. this falsely triggered technical alarm results in that the vaporiser is turned off due to burning issue between the sub 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.
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
Collimator change activities may result in operator injury. a customer advisory notice is issued to advise customers that manufacturer is providing an addendum to the symbia e and e.Cam user manual with specific enhancements to the instructions for collimator change. incidents during collimator change may be avoided by operators properly following specified instructions. once the letter and addendum are provided to customers, it will further reduce the likelihood of the user error occurring during collimator change.
Peruvian data is current through August 2018. All of the data comes from Digemid, 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 Peru.
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.
Testing with a new lot of antibody showed on-board stability claim of 20 hours for dimension vista methotrexate application was not met. lots g2 and h1 (current antibody) showed similar results. further testing on lot g2 showed 4 hours on-board stability.( description of issue – siemens healthcare diagnostics has confirmed that the syva® emit® methotrexate application for the dimension vista® system does not meet the on-board stability claim of 20 hours).
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
It has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all aisys cs2 and upgraded aisys anesthesia devices. aisys cs2 anesthesia devices and upgraded aisys anesthesia devices deliver a momentary, self-correcting increase of the anesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes: a fresh gas setting change from 95%-25% oxygen to only air (21% oxygen). any total flow setting change while using 21% oxygen (air only). the momentary bolus of anesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). delivery of this momentary bolus of anesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable pediatric patients when 21% oxygen (air only) is used. there have been no injuries re ported of 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.
Notas adicionales en la data
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Causa
Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
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
Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
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: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
Causa
Sponsor advised that there is an upcoming revsion of the ifu as women who undergo an essure procedure and an endometrial ablation may be at increased risk for certain events known to be associated with each procedure.
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
Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
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 power plug, which has been delivered with the system is not according to the local regulation in new zealand (as/nzs 3115:2000)., the pins of the plug can be touched when the plug is not inserted completely into the mains outlet, potentially exposing the person to electrical shock.
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 that the product may be labelled beyond its expiration date. a number of units at the manufacturing facility may have been shipped in a package with an inventory label containing an expiration date that is one or more months later than the correct expiration dates shown on the product's primary and secondary packaging., the primary packaging includes a label on each pouch containing individually packaged products. the secondary packaging, which is also the shipping box, also contains a label identifying the product by part and lot number., the correct expiration dates located on the labels of the primary and secondary packaging for these products is no earlier than march 2018, so prompt attention to this notice will prevent expired product from mistakenly remaining in inventory. while month and year are listed, the shelf life extends through the last day of the listed month.
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: Applied Medical New Zealand Ltd, 6/56 Pavilion Drive, Mangere, Auckland 2022
Causa
Manufacturer initiated recall of the ca090 direct drive® clip applier due to increased customer feedback indicating inconsistent clip application. although malformed clips are typically readily apparent to the user, this failure mode may lead to un-occluded vessels.