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) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on.2) when the carescape monitor b650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously.3) when the carescape monitor b650 is connected to the unity id and information from a 3-lead ecg cable is transferred through dri (s/5) network, the monitor may reboot.4) upgrading the software for carescape monitor b650 may not update the software for power management card (pmc).5) when the usb cable connected to the carescape monitor b650 is insecurely connected or faulty and is able to move the monitor may reboot. 6) carescape monitor b650 remote printing issue with currently printing prn 50 recorder.7) carescape monitor b650 reboots due to an x server freeze. it may reboot when the monitor is viewed from carescape cic pro or when the printing is initiated from carescape cic pro.
Acción
GE Healthcare is providing users with work around instructions to mitigate the issue. A software and hardware update will be implemented to permanently fix the issue when 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
Five customer complaints have been received regarding the appearance and performance of the scalpel blade. the customers have complained that the product is sub-standard and unsatisfactory. samples of the device in question were examined and the product was deemed sub-standard.
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
Ge healthcare has recently become aware of potential issues with the carescape monitor b850 as outlined below:1. carescape monitor b850 udom failure. it is possible that the carescape monitor b850 may enter into a constant book loop causing monitor to reboot continuously. 2. carescape monitor b850 unstable usb communication. when the usb cable is connected to the cpu or display is insecurely connected or faulty, the monitor may reboot. reboot may also happen if the monitor display is continuously set on and off several times. 3. carescape monitor b850 remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is busy when the carescape monitor b850 sends a printing request, the printing may not be saved and therefore not printed.4. carescape monitor b850 reboots due to an x server freeze.
Acción
GE Healthcare will be implementing a software and hardware correction.
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
Kerr australia advises that the current directions for use for tempbond ne lists a working time that is not indicative of the actual performance of the product. more specifically, the current directions for use lists the total working time as 90 seconds, while the material actually provides a minimum working time of 60 seconds.
Acción
Kerr Australia is providing updated Instructions for Use (IFU)
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 is the potential for foil degradation on the dgp-hp rfa high power single use grounding pads. this foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site.
Acción
Covidien is recalling the affected lots and replacing it 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
Due to an administrative system failure identified within the company, the product, not currently approved for inclusion in the australian register of therapeutic goods (artg), has been inadvertently distributed to hospitals.
Acción
Quarantine and return affected product to B. Braun
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 following issues have been identified with this product:1. the current system design of software version 4.0.0.Xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for ct brain perfusion scanning, which previous versions did. however, the current version does have the dose check (nema xr-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable dose check after entering their credentials and password 2. when service providers gain a remote connection to the scanner, the scanner does not notify the user that remote access of the system is in effect3. when the interventional biopsy protocol is used, the manual button is enabled on the ct control, but when the user presser the "go" button on the gantry, it may produce multiple scans4. the table and the gantry could get close enough to each other (<25mm apart) which poses the risk of 'pinching' a patient's or technologist's finger.
Acción
Philips is providing a software update to permanently correct the issues.
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 has confirmed analytical sensitivity of greater than the 0.3ng/ml described in the instructions for use with multiple advia centaur prolactin reagent lots and multiple calibrator b lots when run on the advia centaur cp only.
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
The use of the disposable general purpose 9 french temperature probe for nasopharyngeal applications can create, in certain clinical conditions, a potential for severe epistaxis, which may require interventional procedures or prescription medications to properly resolve. these clinical conditions include patients treated with anticoagulants or are at risk for coagulopathy.
Acción
GE Healthcare is recalling all probes and will be replacing them (or providing credit) with new sterile units solely to be used for oesophageal or rectal use and are updating the Instructions for Use (IFU).
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
Pentax has been notified of a potential risk related to the use of the eg-3870utk ultrasound video gastroscope in combination with aspiration needles if the instructions for use is not followed carefully by the user. specifically, if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle could disengage from the elevator.
Acción
Customers are being provided with revised instructions for use (IFU) which should be read and followed by the users of the equipment. The owners manual is to be updated with the addendum that has been provided by the Sponsor.
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 reason for this product recall is due to a packaging issue. specifically, pin holes have been identified in a small number of pouches, which constitutes a breach of the sterile barrier.
Acción
Customers to remove affected units from use and contact the Sponsor to arrange for 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
Elekta digital linear accelerator gantry base wheel bolts have been found to become loose and fail in some instances.
Acción
Elekta is informing customers that all gantry base wheel bolts should be checked and they should be replaced if found to be showing signs of fatigue.
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
Covidien has received reports related to a generator malfunction where the haloflex energy generator fails to enter “standby mode” when initially powered-on. the generator became stuck in the self-test mode upon initial power-on, did not enter standby mode, and therefore could not be used for patient care.
Acción
The customer letter provides temporary work around instructions. Covidien is developing a software revision, which will be available by the end of August 2012 that will prevent the malfunction from recurring.
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 spine has become aware that instruments of the affected lot may fracture at the hex tip of the torque wrench during final tightening.
Acción
Review the Xia 3 instrument trays for the affected wrenches. All affected wrenches must be removed and quarantined until collected or returned.
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 affected lot of cavitec may set slower than indicated in the directions for use.
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
Hill-rom has found that affected affinity four birthing beds, manufactured prior to 21 march 2012, may experience problems with the brakes. this may result in unwanted bed movement.
Acción
Providing work around instructions and correcting with enhanced brake system. This action has been closed-out on 11/02/2016.
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
Abbott vascular has discovered that some percutaneous transluminal angioplasty (pta) catheters may exhibit difficulty inflating and/or deflating.
Acción
Immediately remove and quarantine all inventory of affected part numbers so that they will not be used. Abbott Vascular will replace affected units with similar product, pending availability
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
Packages labelled as short-handled cutters (part number 803-0500) actually contained long handle cutters (part number 803-0501).
Acción
Ormco is asking customers to return the affected lots for replacement or credit.
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 has received complaints of inaccurate results after calibration of hb1c (df105a). accuracy shifts of up to 27%, both high and low, have been reported on qc and patient samples. the shift observed with qc material is consistent with the direction and magnitude of the shift observed with patient samples.
Acción
End user to use updated scaler values for calibration of all affected lots.
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 product registration with tga is not yet complete and this product has been withdrawn pending the tga registration approval.
Acción
Quarantine and return affected products to NeilMed Pharmaceuticals
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
Varian is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
Acción
Onsite inspection and replacement of jaw carriers. This action has been closed-out on 18/02/2016.
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 isolated reports of postoperative fever and inflammatory reactions (in the absence of bacterial infection) with use of actifuse abx in paediatric patients undergoing surgical removal of large juvenile bone cysts. the reported side effects had no negative impact on therapeutic outcome or function of the actifuse product. the instructions for use will be updated to include the reported problems as precautionary statement.
Acción
Updated Instructions for Use (IFU) is being provided to all users of the 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
During the manufacturing process, the sealed edge may not have been uniformly formed and pleats or creases may have been formed which could have the potential to compromise the barrier integrity of the pouch.
Acción
Identify and quarantine affected products. Return the quarantined stock to Device Technologies for replacement stock or credit.
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
Potential for packaging particulate matter to reside on the product.
Acción
Quarantine and return recalled lots to Applied Medical.
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
Due to an incident involving the back rest on an ultima bath chair, the manufacturer has updated the instructions for use (ifu) on adjusting the back rest and pre-use safety checks.
Acción
FAS Therapeutic Equipment is providing customers with amended instructions for use advising that the Ultima Bath Chair should not be adjusted while occupied.