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
This recall action is to alert users that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable.
Acción
AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label.
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
Subsequent to a urgent recall for product correction (tga ref: rc-2013-rn-00126-1) of hvad pump's driveline connector housing become partially or fully separated from the front portion of the driveline connector, heartware have identified an alternative failure mechanism. in 8 cases, customers have reported that the locking mechanism of the driveline connector has failed to engage. there have been no reports of injury. heartware has made changes to the manufacturing procedures to address this issue.
Acción
Heartware is advising users that should the driveline disconnect from the controller, push the driveline connector back into the controller immediately and contact Heartware for repair..
Heartware is advising clinicians to inspect patient's driveline connector as described in the provided technical bulletin for proper locking. For already implanted patients, please arrange a follow up visit at the earliest convenience to check the patient's driveline connector. If the locking mechanism of the driveline connector is found to have failed to engage, please push the connector back into the controller and contact Heartware for repair.
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
Upon power up, the ip5 may fail to produce audio. "audio" includes touch screen tones, qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (ie. waveforms, numeric values, visual alarm indications). this problem will only occur upon power up of the device. accordingly, the scenario where audio is present at the onset of monitoring and then is lost during monitoring will not occur.
Acción
Philips Healthcare is providing users work around instructions to follow as an interim measure. A software update will be installed to correct the problem.
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 pet reconstruction server (prs) database may randomly lock up after the low dose ct acquisition is complete and will not allow the pet acquisition to begin, resulting in an unexpected incomplete study. if this condition occurs, users cannot remedy this issue and will require service interaction prior to the system being operational.
Acción
Philips is contacting all affected customers to schedule service by a Field Service Engineer to install a software update to correct the problem. This action has been closed-out on 12/02/2016.
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
If during system installation, the screws holding the c-arm were mounted using thread locking compound (for example, loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
Acción
Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site.
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 issue relates to fasteners securing overhead lift rail systems to ceilings in chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the stainless steel hardware may occur in the presence of chlorinated environments such as swimming pool areas. there is a risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders.
Acción
Hill-Rom is advising users that an inspection will be carried out on all potentially affected systems located in a chlorinated environment and if systems are found to be of stainless steel hardware, it will be replaced with unaffected hardware. Hill-Rom is reminding users that periodic inspections are required for the rail systems in accordance with the Instructions for Use (IFU). For more details, please see http://www.tga.gov.au/safety/alerts-device-liko-overhead-lifts-140121.htm . 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
Philips has detected a situation where ring artifacts may occur. the conditions that may create these specific ring artifacts occur when a user:1. selects a non-gated helical scan with automatic scan time on 2. they edit the preview images using ‘edit before final recon’ (reconstruction); and,3. the automatic scan time algorithm is executed after the scan has been acquired.Presence of ring artifacts affecting diagnostic quality of images may result in a rescan.
Acción
To avoid the occurrence of these specific ring artifacts users can implement the following work around:
1. Disable Automatic Scan Time for all Exam Cards
2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan.
3. Disable Edit Before Final Reconstruction for all Exam Cards.
If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem.
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 a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/oxygen gas mixture from the unit which could result in hypoxia or hyperoxia.
Acción
GE Healthcare is advising users to perform a blender accuracy check as outlined in the service manual to verify the O2 concentration set at 21% and 100% settings are within the recommended range. If the blender accuracy test results do not meet specification, remove from patient use and contact GE Healthcare. If the blender accuracy results pass, the system is suitable for continued use, however GE is recommending that when delivering oxygen a pulse oximeter is used to monitor the patient.
GE Healthcare will be correcting all affected systems as a permanent fix.
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 manufacturer has initiated a recall due to a product mislabelling which may result in inefficient treatment of the patient and could require further medical intervention to replace the wire.- product labelled as “upper” may contain “lower” archwires with a red midline mark- product labelled as “lower” may contain “upper” archwires with a black midline mark.
Acción
Emergo is advising users to return affected devices for replacement.
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 blue plastic handle of the shear scissors may stain the peel pouch during autoclaving.
Acción
Aaxis Pacific is requesting hospitals and clinics to quarantine all units from the affected batches. Arrangements will be made for the recovery of the stock by Aaxis Pacific and 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
The pentax eg-3670urk flexible endoscope has been qualified for use with the evotech ecr, however it cannot currently be processed in the evotech ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
Acción
Johnson & Johnson Medical is advising users with the Pentax EG-3670URK scope to manually clean and undertake a high level of disinfection prior to use. The EVOTECH ECR can continue to be used in accordance with the user guide for all other endoscopes that have been qualified and validated. A software update will be implemented as a permanent fix.
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
Internal investigation confirmed that the certificates of analysis of the liaison biotrin control parvovirus b19 igm (p/n 317011), lot numbers 130010x, 130010x/1, 130012x, 130012x/1 & 130012x/2, are reporting an incorrect negative control range for the liaison xl application, when used in combination with liaison biotrin parvovirus b19 igm (317010) kit lots numbers 129019x & 129019x/1. the negative control range for these lots of liaison biotrin control parvovirus b19 igm should be 0.0 - 0.5 index instead of 0.0 - 0.3 index as previously reported in the incorrect certificate of analysis.
Acción
DiaSorin has notified their customers of the change to the range of the Liaison Control for Biotrin Parvovirus B19 IgM.
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 system is not turned “off” manually at regular intervals an automatic reset of the large display controller can occur. during the reset the system switches for approximately 1-2 minutes into the “bypass fluoro” mode. during this time only the native fluoroscopic image is displayed.
Acción
Siemens is advising operators of the Artis system to ensure that the system is manually turned off at regular intervals. A software update will be implemented to correct the problem.
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
Asp has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the sterrad systems. odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100s ,sterrad 50 and/or sterrad nx . the reported odours/smells do not impact sterility of the devices processed within the sterrad systems. asp is investigating this issue to determine the source of the odour/smell and will continue to perform planned maintenance in accordance with each system’s schedule.
Acción
If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.
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 has become aware that some outer trays of the trident tritanium acetabular window trials case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray.
Acción
Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product.
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 a potential problem with the zymed holter converter if more than one instance of the program was inappropriately started, the pdf image for patient could be generated incorrectly.This recall action was undertaken prior to agreement of the recall strategy by the tga.
Acción
Epiphany Healthcare (the manufacturer) installed a software patch to correct the software error.
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
Roche diagnostics australia would like to inform users of the possibility of leakage occurring for some batches of cobas® pcr media ivd. these are packaged into different lots via the cobas pcr urine ivd kits and cobas pcr female swab ivd kits.
Acción
Roche is requesting their customers to continue to follow the instructions for use and to inspect each tube or blister pack for evidence of leakage. If leakage is detected the media must be discarded.
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 manufacturer, itc has determined that citrate aptt cuvettes from the lots listed above may recover higher than expected results in normal individuals. itc’s investigation into the affected lots identified that when performing tests on non-heparinized e.G., normal blood samples, results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected. itc has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated aptt baseline may contribute to serious injury.
Acción
Zoll Medical Australia is requesting their customers to inspect their stock and quarantine all affected lots of the product. Zoll Medical Australia will arrange for the recovery and replacement of stock. Customers are advised that the requirement for retesting reported patient results should be discussed with the 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
Siemens healthcare has confirmed over-recovery of samples with concentrations greater than 5.5ng/ml (19.2nmol/l) with the immulite/immulite 1000 and immulite 2000/ immulite 2000 xpi androstenedione assays. siemens has determined that these lots are linear up to a concentration of 5.5ng/ml (19.2nmol/l), instead of 10ng/ml (34.9nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5ng/ml (19.2nmol/l) and 10ng/ml (34.9nmol/l) will detect this issue.
Acción
Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.
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 an overall average positive bias of 23% against the who 2nd irp 75/502 with the immulite systems total ige assays. the immulite total ige controls will not detect this bias. this issue is not expected to impact patient care since the observed bias in values would not impact selection for omalizumab therapy for asthma.
Acción
Siemens is providing laboratories with this information to allow informed clinical decisions when undertaking Total IgE testing. There are currently no unaffected batches available in Australia. A lookback of previously generated results is a the discretion of the laboratory.
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 femoral implant/tibial baseplate combination of the journey bcs knee system has been identified in the australian orthopaedic association’s national joint replacement registry (aoanjrr) as having a higher than expected revision rate when compared to all other primary total knee replacements.. the aoanjrr data indicates that journey bcs has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. the most recent journey bcs knee system revision data published by the njrr include: - a revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and- a yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements. smith & nephew is withdrawing the femoral implant component of the journey bcs knee system from the market.
Acción
Smith and Nephew is recommending that surgeons contact their patients who have been implanted with the Femoral Implant component as part of a primary knee replacement surgery and inform them of the current alert. Surgeons are advised to maintain standard follow-up protocols and actions for the care of their patients. Smith and Nephew do not recommend pre-emptive removal. Revision should only be undertaken when there are symptoms related to implant failure. JOURNEY BCS will no longer be available as a primary knee replacement system. The UHMWPE inserts of the JOURNEY BCS Knee System continues to be available for revision use. For more information, please see http://www.tga.gov.au/safety/alerts-device-journey-bcs-knee-replacement-system-140106.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 user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism., the swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is lose, the entire module may fall off the ultrasound system. there is a potential risk of striking and harming anyone in the environment of the ultrasound system.
Acción
End users are advised to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. If looseness is observed, discontinue use immediately and contact a Siemens service representative. A service engineer will perform the necessary repairs.
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 treatment table, gantry and collimator calibration procedures, it is possible to type the incorrect values or invert a value. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibration. this could result in delivering the treatment with the patient in the incorrect position resulting in clinical mistreatment.
Acción
Users are asked to undertake QA procedures in accordance with the instructions for use (IFU) for Integrity, Precise Table and X-ray Volume Imager (XVI). Users will be informed of the mandatory software upgrade upon its release (expected early 2014) which will mitigate 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
Two reported incidences have occurred since the product was first released in december 2004, where the upper base casting has fractured. the looseness or removal of the four screws that locate the base plate to the upper base casting may allow the base casting to be distorted or weakened under load and possibly fracture if excessive force is applied.This recall action undertaken in february 2013 was carried out prior to the approval of the recall strategy by the tga.
Acción
Sunrise Medical is advising users that affected units will be upgraded as part of the next scheduled inspection. This action has bee closed-out on 12/02/2016.
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
Ge healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the list mode replay feature of the discovery 600 and discovery 690. a software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions and may lead to image misinterpretation and/or inaccurate treatment decisions.
Acción
To avoid this potential issue, GE Healthcare is advising customers to implement temporary workaround instructions through the customer letters. GE Healthcare will provide a software update for all affected systems to address the issue permanently.