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 kirschner wire is made from co35ni35cr20mo10 (mp35n) which is cobalt based alloy containing 35% nickel. however, the label and technique guide incorrectly indicate that the devices are made of stainless steel., the product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices., please note: - product shipped in "kits" in new zealand are not in packaging and therefore not labelled.
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 insertion handle may break when struck with a hammer during the nail insertion process.
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.
Incorrect drug dosage due to "age limit" data item issue:, when there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated, a stale creatinine clearance (crcl) value is being used in area under the curve (auc) dose calculations., incorrect drug dosage due to patient weight data item issue:, if there is a valid age limit added to an elekta metric data item (eg; weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (eg; weight (lb) ), the calculated result which has no valid age will still be considered valid and could be used in drug calculations., if a stale dose calculation is used in dose calculations the dose may be incorrect.
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: Alphatech Systems Limted, 630a Great South Road, Greenlane, Auckland
Causa
When the electrical lift table is connected to the mains power in a very rare occasion the table may start to move up in an uncontroled manner.
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
Calcualated leads, also referred to as reconstructed ecg leads viewed or printed at the information centre ix may misrepresent the ecg waveform in specific leads., lead combinations that are affected:, lead 1 and lead 111 are used to derive the avl lead (incorrectly derived), lead 1 and lead avr are used to derive the avl lead (incorrecty derived)', lead 111 and lead avf are used to derive lead 11 (incorrecty derived).
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: Surgico Medical & Sugical Ltd, Unit A, 3 Whetu Place, Rosedale, North Shore City, AUCKLAND 0632
Causa
A specifit lot no of product was labelled with an incorrect expiry date of october 2018. the correct date is march 2017.
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 been advised that some clinics overseas are using substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly contain and cooling the skin and cause minor burns and blisters., whilst there have not been any adverse events reported in australia, device consulting is conducting a product correction to update the user manual for the miradry system to include the statement:, “do not use lubricants other than the recommended lubricants k-y® jelly or k-y® liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Potential sterility breach., a failure has been discovered during routine quality control at the manufacturing site., this failure may cause a small hole, (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier., after identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected lots., manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014., .
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.
Manufacturer has received a customer complaint advising that have found tubes containing a white powder. one of these tubes had been used on a patient to measure troponin levels, generating a zero result. patient retested using another tube that did not contain the white powder and different result obtained.
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
The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, Blood Culturing - Product Code MDB
Causa
A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
Acción
Consignees were notified by letter on May 27, 2005.
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
The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
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
The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
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
The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
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
The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
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 production process used to package the affected lots of herculite ultra, herculite xrv, point 4, and premise may lead to the presence of plastic particulates in the dental composite material.
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 the instructions for use (ifu) included with the products listed in attachment #1 distributed from june 2013 to june 2015 provide the incorrect inflation volume. the inflation volume provided on the catheter's valve cap does state the correct inflation volume. the ifu contains a chart entitled recommended inflation volumes with incorrect volumes.
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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
Causa
In the course of product monitoring, some cases have been reported in which the "poti unplugged" error message was generated. in those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating., no patient injury has been reported due to this issue., the error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). the increased resistance is caused by an oxide layer formed on the controller over a lengthy period of time. the oxide layer can only form if the controllers are rarely or never moved and according to our product monitoring, some users never, or rarely, use the fio2 controller.
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
Product not meeting current high-dose hook effect expectation in 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.
Manufacturer has recently become aware of a potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment., in aqure, there are two views called flexlink and patient view. each can display multiple patient result values from a single patient, provided over time, from one or multiple devices. this screen is intended to be reviewed by a clinician., the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) is compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”.
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
Potential for suspension arm with monitor assembly to fall to the floor.
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.
Manufacturer has initiated a recall due to the need to clarify operator actions folloing u90-382 or 6lu cnditions codes generated by the system., if a u90-382 or 6lu condition code (i.E associated with a wash error) occurs, the condition code text located on the vitro system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios., this notification provides additional information to a product correction notification that ortho clinical diagnostics (ortho) issued in december 2015 (medsafe ref. 19634) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors. we observed an increase in wash errors for vitros chemistry products phyt slides.
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 extraction screw from the affected product lots could break or disassemble from the instrument. this could interfere with removal of the instrument from the patient.