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
When epiq 5 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., using patient's weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
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
When epiq 5 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., when using both height and weight to calculate the bsa, which is the usual practice for patients above the age of 2 years, the result may be too high by a factor of about 10, an error that would be readily identified by the user.
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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
Causa
Medline is recalling certain lots of procedure packs which contain covidien devon light gloves. these light gloves may contain splits and pin holes. if a clinician touches the handle unaware that the light glove is split and or contains pin holes, micro-organisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection. medline is recommending that a light cover is discarded at the time of the surgical 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: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
Causa
A smith and nephew investigation found the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter's sharp edhges from potentiallypuncturing the pouch and rendering the device unsterile.
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 current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 mcg/ml (688 umol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool., based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 mcg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool., the package insert is being updated accordingly based on these results.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The manufacturer is recalling this product due to a possible breach of the package's sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen.
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
Covidien has recalled these devices following reports from customers, where patients who recently switched from the current shiley™ neonatal and pediatric products to the affected products, experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch.
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
Covidien has recalled these devices following reports from customers, where patients who recently switched from the current shiley™ neonatal and pediatric products to the affected products, experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch.
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.
Resmed is updating the instructions for use to change the intended use statement and add a contraindication following the results of a recent clinical trial.
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.
Resmed is updating the instructions for use to change the intended use statement and add a contraindication following the results of a recent clinical trial.
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.
Resmed has initiated a recall for product correction following a single incident overseas, in which an astral ventilator had been disconnected from a high-dependency patient without an alarm sounding. it was later found that a health professional had disabled all of the alarms that would normally indicate disconnection.
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.
When vmat control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate. such plans will never be generated by raystation and imported plans with this wide gantry angle spacing will normally not be possible to use for dose calculation in raystation. however, if the imported plan is assigned to a vmat enabled machine model with minimum dose rate = 0.00 mu/min and minimum gantry speed = 0.0 degrees/s, it is possible to calculate dose., , depending on the individual plan, local dose inaccuracy in some regions close to the patient surface may range from under a percent to several percent of dose max. the deviation increases with the gantry angle spacing and with the number of affected control points. the problem will mainly occur in the region furthest away from the isocenter.
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
When epiq 7 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., using patient's weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
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
When epiq 7 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., using patient's weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
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
When affiniti 70 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., using patient's weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
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.
Abbott diagnostics is recalling alkaline wash lot number 49059un14 due to leaking product and/or material received with loose bottle caps that may have leaked during shipment. alkaline solution is corrosive and the operator can be exposed when the bottle is leaking.
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 that a number of lots can lead to the failure of calibration on sysmex® ca-1500, ca-7000, cs-2000i, cs-2100i, and cs-5100 instruments., in case the berichrom protein c calibration curve on the above mentioned systems is indicated as being invalid due to the 0% point of the calibration by "reaction curve error", the measurement signal does not meet the instrument's check algorithm for at least a value of 0.001dod and therefore this point gets flagged., follow-up communication, the manufacturer has issued a new protocol disc version with new and enhanced assay applications for sysmex cs-2000i/cs-2100i systems. this also includes a new protocol disc version with new and enhanced assay applications for sysmex cs-2500 systems and on sysmex cs-5100 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.
Ossur is recalling this device due to the outer tube threads not being machined correctly. use of the affected product may cause the patient to fall, as the shock module can become loose from the foot blade. the failure could possibly be noticed by users as they will feel looseness on ankle foot device. if use is continued, connection of shock adapter to foot blade might break and user may fall.
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 Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
It has been determined that the evotech® endoscope cleaner and reprocessor (ecr) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. the likelihood of this occurrence is low, and asp has not received complaints or reports of adverse events related to 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
Siemens has identified 2 issues when using dimension vista analysers with specified software versions., 1/ samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable., 2/ complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronization during the automatic removal of reagent cartridges from reagent server 2 to waste a container.
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: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
Causa
Images successfully transmitted to intelepacs may not be available for reading in all studies. this failure can be detected if the client has image count verification protocols. this failure can also be detected if complete series are missing as the user will know to look for those missing series. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy, which is also highly detectable. however, under certain circumstances it can appear as if the study is complete with no user observable means to identify the failure. no patient incident has been reported to date.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: Biotronik Australia Pty Ltd (NZ), 44 Cornwall Park Ave, Epsom, Auckland 1051
Causa
The manufacturer has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent.
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: Biotronik Australia Pty Ltd (NZ), 44 Cornwall Park Ave, Epsom, Auckland 1051
Causa
The manufacturer has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent.
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 observed a system-to-system bias between the tni-ultra™ assay on the advia centaur® cp and advia centaur/advia centaur xp/advia centaur xpt systems with the advia centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system. siemens is actively pursuing the cause of this issue., this observation impacts customers who use the tni-ultra assay on both the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems interchangeably when interpreting serial testing in patient samples. this communication does not impact customers who use tni-ultra results solely from either the advia centaur/advia centaur xp/advia centaur xpt system or the advia centaur cp 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
Causa
Varisource ix console software version 1.2, build 2.4336 will occasionally freeze during the treatment initiation sequence. an application freeze is a condition when, after pressing the deliver treatment button the the treatment delivery strip, the treatment delivery strip becomes blank and the afterloader remains in idle mode and does not switch to treatment delivery mode. no other buttons on the control software user interface will respond. as a consequence of a system freeze there is the potential for the partial fraction generated by the system to be incorrect.