Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).To be more precise, heating may occur if each of the following conditions applies at the same time:- coil positioned off-center in head-foot direction by more than 5cm- coil at side position- application of higher rf power over several minutes.In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
Acción
Siemens is providing work around instructions for users to follow.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been identified that there is a possible fault in the affected batches due to inadequate bonding between the coating and substrate in manufacturing, which may cause insulation to crack and lift away from the metal body.
Acción
Customers to identify and segregate any units from affected batch number and contact the sponsor to arrange return of recalled stock and order replacement stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Philips has learned that the vsi/vs2+ patient monitor may not be properly secured to the gcx wall mount, which may go unnoticed. this may cause the vsi/vs2+ patient monitor to fall from the wall mount which could injure a user or patient.
Acción
Philips Healthcare is providing work around instructions and will be implementing a hardware update for all affected devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
As a tga condition for product registration, the genscreen hiv ag/ab ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. the genscreen hiv ag/ab ultra kit was distributed to customers after may 2011 without the warning label: "customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
Acción
Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been reported to the sponsor that the boxes labelled as part number 972-3025, which is the size #25 obturators, actually contain inner packages of size #30 obturators. although an inconvenience, the product will function as expected.
Acción
Return affected lots to Ormco for replacement with unaffected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Acción
No action needs to be taken at this point by the customer or user. Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Hospira has received reports from customers of drum cartridge catheter reports of the drum catheter dismantling/uncoiling before or during use/insertion. there have been complaints related to difficulty in inserting the catheter, leaks and separations, breakage of the catheter inside patient during insertion.
Acción
Hospira is asking customers to immediately quarantine and return the affected stock for credit. Hospira is not going to continue to supply this product and is suggesting customer identify alternative products.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
There have been reports received of a "fault in motor controller" alarm message. if this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
Acción
Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Manufacturing tolerance's of the standard cranial reference array influence the actual position of its marker spheres. the differences between the individual arrays are very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery.This recall action was not notified to the tga before it was initiated by brainlab australia.
Acción
The sponsor is advising users to follow work around instructions and will provide a hardware update to correct the issue.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
1.The device may turn itself on without input from the user. when this occurs, the normal sequence of audible prompts will be emitted from the device. if this issue continues undetected, the battery will eventually become completely depleted below the minimum battery capacity necessary to allow for the delivery of therapy.2. certain devices may misinterpret a temporary drop in battery voltage as signalling low battery. this issue will result in the device prematurely displaying the low battery warning and turning itself off even if sufficient battery capacity remains. if the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device will only deliver one shock before turning itself off. devices containing software version 1.4.2/ 3.2.0 or higher are not susceptible to this issue.
Acción
Keep the devices in service. Follow the instructions from the sponsor to order a reserve battery pack and to download the new software. Aero Healthcare has advised the TGA that there are about 120 HeartSine PAD 300/PAD 300P units which could not be located during the recall. For more details, please see http://www.tga.gov.au/safety/alerts-device-heartsine-pad300-pad300p-131010.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
On some occasions during surgical procedures, the unit will fail, alarm, lock into a non-operational mode and the display screen will go blank. based on zimmer's investigations, this problem is due to a defective chip on the control board.
Acción
Customers are being asked to remove affected A.T.S 3000 tourniquet systems from use immediately & contact their sales representative who will return the unit to the company for repair and arrange a loan unit.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The birmingham hiptm modular head (bhmh) as part of a total conventional hip replacement system has been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in addition, most of the revisions that are occurring later (after the third year) are linked to metal sensitivity and infection.
Acción
Smith & Nephew is advising implanting/treating surgeons on how to manage patients implanted with the Birmingham Hip Modular Heads. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-bhmh-121030.htm
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The architect havab-igg assay shows a shift in the serum and plasma results to higher s/co values over time, potentially leading to reduced specificity and increased false reactive results. the expiration dates for all affected reagent lots are being revised.
Acción
Abbott is providing work around instructions for users to implement until permanent preventive measures are implemented.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
If the xl defibrillator/monitor (m4735a) is used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Acción
Customers are being advised to identify whether they are using the defibrillators with a defective battery and to operate the affected HeartStart XL Defibrillator/Monitor using AC power supply only. Philips will be providing affected customers with a replacement battery(s) as soon as a new production of batteries are available.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Bd has determined that the bd max instrument may have minor defects that could cause the instrument to malfunction yet is unlikely to cause erroneous results. the minor defect(s) may be due to the following:1) a potential misalignment of the filters/lens in the reader assembly that can produce reaction curves with excess variability2) a supplier defect on a limited number of mux heater board assemblies.
Acción
Becton Dickinson Service Associate to inspect the instrument and perform corrections if required
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
A patient was mistreated after a user made and saved an inadvertent change to the definition of a treatment field in mosaiq. the mistreatment occurred at a site that had disabled the field edit display feature.
Acción
Elekta is providing instructions to enable the Field Edit Delta Display Option and recommends upgrading to software version 2.41 or higher
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The sponsor has confirmed the potential for falsely elevated results with iron flex reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has identified an increase in the mean values obtained with the loncm control lot 0022 when used with immulite/immulite 1000 osteocalcin (lkon1, smn 10361396) kit lots 313 and above. siemens is providing revised control targets and ranges.
Acción
Siemens is providing work around instructions for users to implement.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Acción
Philips Healthcare is advising users of the issue and will be completing a repair of all affected systems.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The current directions for use for tempspan cmt lists a working time that is not indicative of the actual performance of the product. the current directions for use lists the total working time as 60 seconds, whereas the minimum working time is 45 seconds.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Stryker orthopaedics has become aware of a potential packaging issue associated with various products, potentially affecting sterility of the devices.
Acción
Quarantine the affected devices identified in customer letter from Stryker.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Given imaging has received reports of failures of the pillcam during normal use and when the product was used in a manner that was not supported by its design specifications and tolerance's.
Acción
Given Imaging is recalling all affected devices and ceasing supply. There are alternative products available for customers.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Philips healthcare has received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. the problem can occur when the scan was in "ready to scan" or scanning mode. there is a risk of undesired radiation due to the potential for a rescan if this issue happened during scanning mode.
Acción
Philips Healthcare will be installing a software update to address the identified issue.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The annual reports of the australian national joint registry [njrr], have indicated a higher than expected revision rate for this prosthesis since 2010. the 2011 njrr report indicated that the cumulative revision rate for the device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. the revision rate for the implant continues to be higher than that of similar implants being used in australia. the apex k2 stem has not been available for implantation since early october 2011.This device has now also been cancelled from the australian register of therapeutic goods as well as the private hospital prosthesis list.
Acción
Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm