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: Starkey Laboratories New Zealand, Unit 1, 710 Great South Road, Penrose, Auckland 1061
Cause
It has recently been reported that an unattended child aged 7 months has required treatment to remove an earmould from the larynx. to ensure the safeguarding of the products the manufacturer has taken new steps to further improve the safety of the earmoulds for young children and have implemented a successful method of securing a tube into a silicone earmould with a bonding glue to prevent the detachment of the earmould.
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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
Cause
The manufacturer has identified that the barcode label for the optilite special wash 1 bottles is incorrect and will not be recognised by the optilite analyser. the affected bottles cannot be used to complete the special wash step.
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: Fresenius Medical Care Australia Pty Ltd (NZ), 60 Pavillion Drive, Airport Oaks, AUCKLAND
Cause
The manufacturer has undertaken a review of the hazards identified with the use of the 5008 paed therapy system and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, the manufacturer are limiting the intended use to >17 kg of body weight.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has recently become aware, through its post-market surveillance processes, of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to "stent folding".
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has recently become aware that the abl800 series analysers could potentially result in a mix-up of patient results when confirmation of demographics is enabled as part of the query to aqure, radiance, or a his lis system. please note that the default setting for this function is 'disabled'.
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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
Cause
The manufacturer has found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector.
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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
Cause
The manufacturer has found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector.
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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
Cause
The manufacturer has found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector.
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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
Cause
The bact/alert virtuo instrument firmware version r2.0 allows relocation of the four (4) resident calibration standards so that field system engineers (fse) can service the associated cells p24 - p27, where the calibration standards typically reside. if the calibration standards are not returned to the designated locations, an anomaly may occur.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has recently become aware that the abl800 analysers that measure ccrea may potentially report lower than expected ccrea results on patient samples., the difference has been reported to be as high as -28%., currently, this problem may not be caught by running qc, as the qc will be lower, but still within range.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has indentified an issue found with the dmlc "sliding window" photon dose calculation in raystation 4.5, raystation 4.7, raystation 4.9 (rayplan 1), raystation 5, raystation 6 (rayplan 2), raystation 7 (rayplan 7) and raystation 8a (rayplan 8a) for machines with jaw movement per beam, x-jaws and where the mlc is not above both jaws (i.E., varian style linacs). if the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of dmlc fields when the collimator is rotated.
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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer is notifing customers of the changes to the ifu consising of an editorial revision made to ensure clarity and ease of use of the zenith alpha™ thoracic endovascular graft. the update of the ifu is not initiated based on a safety 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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer is initiating recall of the cook chorion villus biopsy needle set (echo tip) ck-k-cvns-1821-robinson-et. the diagram on the product label is incorrect. it shows that the 18ga needle has an echotip, and the 21ga does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.
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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Cause
The manufacturer has identified an issue in apple ios 11.3 & 11.4 that can sometimes prevent you from receiving a 'lost communication' alert after your guardian™ connect app is closed by the iphone's operating system (ios) in certain situations. the operating system may close the guardian™ connect app without alerting the user that the app is no longer running or communicating with the guardian™ connect transmitter.
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 potential for positively biased sample results to occur when using the affected vitros na+ slides. results for serum/plasma and urine samples obtained using vitros na+ slides listed above may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.
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
The footplate of the patient support for stitching can be fixed in upper position. when the fixing clamp (hook) is not in its correct locking position, the footplate is not securely held. if it falls down, it may hurt the operator's or patient's foot or leg (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the footplate up).
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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
Cause
The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). the manufacturer has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the cause leading to this issue are., 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set., 2. a higher cracking pressure of the back check valve.
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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer will be implementing a new revision of the instructions for use (ifu) for the mreye flipper pda closure detachable coil and flipper 35 pda closure detachable coil delivery 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.
Notes supplémentaires dans les données
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Cause
The manufacturer will be implementing a new revision of the instructions for use (ifu) for the mreye flipper pda closure detachable coil and flipper 35 pda closure detachable coil delivery 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.
Notes supplémentaires dans les données
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Cause
In case of a short-circuit within the x-ray tube a leakage current might cause an overload of the x-ray generator. if this leakage current keeps undetected it may damage the generator by overheating.
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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Cause
The manufacturer has become aware of the potential for a device reset to occur in percepta™ crt-p mri surescan and percepta quad crt-p mri surescan due to a timing interaction between the effectivcrt diagnostic and the ventricular safety pacing feature (vsp).
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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Cause
The manufacturer has become aware of the potential for a device reset to occur in percepta™ crt-p mri surescan and percepta quad crt-p mri surescan due to a timing interaction between the effectivcrt diagnostic and the ventricular safety pacing feature (vsp).
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer has become aware that the product labels (pouch and carton) for synchro 2 products contain an incorrect value in millimetres (0.036mm) for the guidewire outer diameter dimension. the inches dimension (0.014in) on the label is correct. the correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.