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
Ge healthcare has recently become aware of a potential safety issue involving the breakage of the steel cable which supports the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there have been no injuries reported as a result 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Causa
Philips healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. no injuries attributed to the problem have been reported.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer is updating the instructions for use to include additional instructions and warnings when these devices are used for some gynaecological applications.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
Causa
The safety and performance of these devices have not been properly evaluated and so the ce marking of the device is not valid.
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
A ge healthcare internal quality inspection has found that the power cord connecting directly to the t2100 and t2000 treadmills may not have been assembled according to specifications. if the power cord was improperly assembled and a separate secondary electrical fault condition exists (e.G., a frayed extension or power cord touching the treadmill chassis), this could possibly result in an electrical shock to the patient or operator. there have been no reported incidences of the treadmill power cord leading to an electrical shock of a patient or operator at this time.
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
The manufacturer advises that the type iii sample diluents of batches 341738 and 347336 provided in the above kit (lot numbers 341492 and 347294 respectively) may contain microbial growth. the identified contaminant is not present in all diluent vials but has been identified in some, in the form of either white or black matter of an organic appearance.
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.
Internal investigations demonstrate that some lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with specific lots of the the elecsys cmv igm assay., a certain lot of a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one specific antigen included in the cmv igm assay.
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: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
Causa
Manufacturer has been made aware that frame components are substandard and have the potential to fail in use potentailly endangering the health of the user. the frame knuckle joints, found on each side of the simba logo sticker, have been produced using an incorrect method of manufacture causing a reduction in component strength and must be replaced to ensure continued safe use of the 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.
Teleflex medical is recalling the products referenced above due to a possibility that the packages may contain foreign material, (predominantly synthetically derived pvc). this foreign matter has only been found in the package and not in the gas flow path of the humidifier 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.
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 healthcare diagnostics has confirmed a positive bias with the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek™ tumor marker control when used with immulite® 2000/immulite® 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313., in addition, a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above., when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml., future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
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 Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Causa
Smith & nephew advise that a batch of the genesis ii knee system non-porous tibial base plate was manufactured with a surface finish that did not meet the product specification. this could result in poor cement adherence and the loosening of the base plate. the device may fail, and revision surgery may be required.
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.
Notas adicionales en la data
Causa
Does not meet the requirements of good manufacturing practices (gmp).
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
Ge healthcare has recently become aware of potential inconsistencies in the completion of certain device corrections related to the subject product corrections. devices are to be inspected to ensure the previous corrective actions have been conducted appropriately.
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
Ge healthcare has recently become aware of potential inconsistencies in the completion of certain device corrections related to the subject product corrections. devices are to be inspected to ensure the previous corrective actions have been conducted appropriately.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Causa
The mrx could reboot once in any operating mode if the following sequence occurs:, 1. in service mode, the status log is cleared, 2. prior to exiting service mode, the mrx generates an entry in the status log., 3. service mode is exited., , the mrx is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. the mrx will restart within 8 seconds., note: if a reboot occurs during clinical use, current device settings and patient record are retained.
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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
Causa
The mrx could reboot once in any operating mode if the following sequence occurs:, 1. in service mode, the status log is cleared, 2. prior to exiting service mode, the mrx generates an entry in the status log., 3. service mode is exited., , the mrx is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. the mrx will restart within 8 seconds., note: if a reboot occurs during clinical use, current device settings and patient record are retained.
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: Jackson Allison Medical and Surgical Ltd, 56 Lunn Ave, Mt Wellington, Auckland
Causa
The infant heel warmers labelled with prism healthcare do not have an expiry date or lot number on the packaging.
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 manufacturer has updated the instructions for use to better explain the selection and sizing of the grafts for patients.
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 advises that some units of bd q-syte luer access split septum device have an off-centered slit in the silicon septum resulting in a thinner column wall. when actuated, units with a thinner column wall may tear leading to leakage of insuate/medication or blood from the side vent opening.
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 orthopaedics has received complaints regarding the disassociation of the cross pin from the action triggers of the triathlon distal capture assembly, which could lead to a loose or disassociated action trigger mechanism and/or loose or disassociated cross pin.
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
There is a mismarking in the product packaging. the suffix -vc means that the product should be with a vacuum control handle, however with this particular lot no the packing contains the standard 6061616233 product without a vacuum control hole in the handle.
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.
If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical negative pressure limiter (npl) valve. the npl valve opens if the patient generates a negative pressure of -5 and -7.5 cmh20 (hpa). this opening pressure of the npl valve is defined at an inspiratory flow rate of 3.5-4.5 l/min. if the patient creates a higher flow rate than 4.5 l/min, the npl valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further.
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 manufacturer has received reports of the ventilator display feezing. in these cases, the red alarm lamp on top of the ventilator monitor blinks and a high-priority audible alarm is triggered, but no alarm message is displayed. the patient's ventilation continues but the screen is no longer updated and the user can no longer operate the device.
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 (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
Causa
The affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during 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.
The architect anti-hbc ii assay shows lower calibrator, control and sample rlu values, potentially leading to reduced specificity and increased false reactive results., internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. cosnequently there is the potential for false reactive patient results. note that assay sensitivity is not impacted.