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 has been noted that upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification (e.G. imaging). this description is not relevant for an iguide workflow (6d). the problem occurs only when you switch from a 6d to a 3d workflow without iguide.
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 received multiple customer complaints indicating some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert ranges with high cvs.
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
The manufacturer has identified that some ct systems may have a damaged cable that can expose 120vac to service engineers working inside the gantry. this issue does not affect patients or operators external to the equipment.
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 developed an improved da vinci xi and da vinci xr srk tool. the new srk tool design, 1. reduces the likelihood of srk tool breakage; and, 2. does not change the instructions for use.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Cause
The manufacturer has become aware that five warning statements are missing from the intellivue mx40 ifu for software revisions b.05, b.06 and b.06.5x.
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 received a complaint of a akron tilt table middle section frame breakage. the investigation showed that one of critical welds in the part was missing. please note that not all devices are affected by this defect.
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 determined that the irradiation dose qualified for sterilization of the askina gel 15g and askina calgitrol paste was too low. the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 1x10-6.
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 determined that the irradiation dose qualified for sterilization of the askina gel 15g and askina calgitrol paste was too low. the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 1x10-6.
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
It was identified that a transient interruption of the electrical connection between the hvad system power source and the hvad controller can occur under 2 configurations that may result in unintended power switching to the secondary power source and/or unexpected audible tones.
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 identified that the internal mains does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0.
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
The manufacturer has indentified that the large display does not show an image due to a technical problem. this might occur after the large display returns from power save mode. the large display stays black without showing an error message. x-ray is still possible. the problem occurs sporadically and only when the display is returning from power save mode. it does not occur during an ongoing 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.
The manufacturer has identified a potential issue where specific lots for accu-chek inform ii test strips are not meeting product specifications. the issue has coincided with an observed higher than expected amount of strip errors before dose and an increased potential for biased results. investigation of returned, complaint test strips identified cracking of the reagent and underlying electrode as the cause of the failures.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: BOC Limited, 988 Great South Rd, Penrose, AUCKLAND
Cause
A recent incident with the equinox advantage led to the oxygen supply to the patient being cut off. the manufacturer has determined that the fault was caused by a disengaged piston seat in the equalizer that has now been redesigned, to ensure this problem does not reoccur.
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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
Cause
The vent plug of the arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. after the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit., in some cases it has come to the manufacturers attention that the vent plug has broken during the separation from the arterial cannula.
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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
Cause
The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
Cause
The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
Cause
The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
Cause
The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
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.
A bug has been discovered in versions 6.0.1 and 6.0.2 of cellavision di-60 software where some comments are not sent to lis., the problem occurs only when a specific workflow involving multi-slide is selected as described below:, a)multiple slide workflow is selected (i.E. > 1 slide is analyzed on a sample no.), and, b)operator adds a comment on the last slide in the wbc, rbc or plt comment boxes in the di-60 sw after it has been signed/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 has confirmed dimension gentamicin (gent) lot bb8159 may exhibit inaccuracy for quality control (qc) and patient samples at the low end of the analytical measurement range. maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/l [1.94 µmol/l] and 1.9 mg/l [4.1 µmol/l], respectively. patient samples at 2.6 mg/l [5.62 µmol/l] did not show a bias. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators.
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 has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
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 has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
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 has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
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 has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
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.
Manufacturer has identified that all prismaflex control units exhibit a failure mode with the pump module electronics. the failure mode may result in a voltage out of range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. manufacturer will be releasing new firmware that will prevent the malfunction from occurring.