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 identified rms refrigeration compressors that are missing the safety cover on the electrical termination block. the exposed electrical hazard on the electrical termination block is located directly behind the rms waste container. the absence of the safety cover results in a potential electrical hazard to the operator. this issue does not impact patient results.
Acción
Siemens is providing a safety warning to be placed on the machine as an interim measure. A service engineer will be inspecting all units and installing a cover where 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
The manufacturer has advised that some of the hba1c501 test cartridges may give elevated results. as the hba1c501 is used to provide the average glucose concentration over a period of time for patient management and not immediate treatment, an elevated result would not impact patient management.
Acción
Radiometer is advising users to discard any remaining stock. This action has been closed-out on 18/08/2016.
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
Bard medical division (bmd) has identified that the arctic sun 5000 temperature management system with certain serial numbers may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery. the exhausted battery will prevent the arctic sun temperature management system control panel from launching software and initiating operation. this presents a potentially serious issue since the system is used to control patient temperatures within a pre-set range and has the potential of not being available to provide therapy when needed.The issue identified however does not affect an arctic sun 5000 once it is successfully powered up since the batteries are no long being called upon and the unit is operating on mains power.
Acción
The sponsor is advising the user that if the device is currently in clinical use, it can continue to be used without concern for this failure. The battery drainage issue only occurs when the unit is off and in stand-by mode. The sponsor will arrange for a technician to come to the user's facility for the evaluation and potential replacement of the affected electronic components. This action has been closed-out on 26/08/2016.
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
The artus c. trachomatis plus kits are designed to detect a 106 bp region of the chlamydia trachomatis chromosome and a 111 pb region of the crypticplasmid of c. trachomatis; however, the kits fail to detect the chromosomal target. the kits do not detect cryptic-plasmid-free variants.Accordingly, qiagen will be amending the instructions for use of this product to remove the claim that the product can detect cryptic-plasmid free variants of c. trachomatis.
Acción
QIAGEN is advising users to be aware that cryptic-plasmid-free variants of C. trachomatis are not detected by the kits. QIAGEN is advising a review of negative patient results is at the discretion of the Laboratory Manager. This action has been closed-out on 24/08/2016.
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
It has been reported that some i.V. poles were retracting / lowering from an extended position to a low height unexpectedly. the i.V. latch housing has been identified as non-conforming, which has resulted in the suspended i.V. pole retracting.
Acción
Stryker is advising users to identify any of the stretcher models listed on which there may be an affected I.V. pole and place the pole at the lowest position. Stryker are supplying a sticker to be placed on the I.V. pole until the affected poles can be repaired. This action has been closed-out on 05/09/2016.
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
The user may misinterpret still images as live images under following circumstances:1. if while performing fluoroscopy, the user also depresses the single shot exposure pedal, resulting in a single shot still image being acquired and displayed on the screen. the live fluoroscopy is not resumed until the single-shot exposure pedal is released. 2. on systems with multiple fluoroscopy pedals and modes (such as biplane systems), if while fluoroscopy is active in one mode, the user also depresses a second fluoroscopy pedal for a different mode and then releases the first fluoroscopy pedal, the system will stop live imaging and display a still last image hold ) image.Then the device ignores the second pedal until both fluoroscopy pedals have been released.Mistakenly interpreting still images as live images during interventional or diagnostic procedures can lead to unintended positioning of interventional and diagnostic devices and potentially resulting in patient injury or death.
Acción
Philips is advising the users to follow the instructions given in the customer letter and the IFU when operating the device as follows:
- Be aware of the indicators related to X-ray on as described in the Instructions for Use (IFU).
- Be aware that it is not possible to perform fluoroscopy and exposure at the same time.
- USE ONLY ONE PEDAL at a time for image acquisition OR live imaging.
- Be aware that pressing a single shot exposure pedal results in a still exposure image being displayed. No new image is acquired as long as the single shot exposure pedal remains pressed.
- Always release the activated x-ray pedal after completion of image acquisition.
- Philips recommends the usage of an audible signal (X-ray buzzer) during live imaging. If your X-ray buzzer has been disabled, contact Philips if you decide to enable it as an additional safety precaution.
Philips is working with the TGA to determine whether any further risk mitigation actions are required. This action has been closed-out on 04/05/2017.
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 potential vacuum leak may occur around the glass rod sensor in the waste reservoir, caused by the gasket on the housing of the glass rod sensor sliding out of position. if the error occurs, the analyser will alarm and no results will be generated.
Acción
Siemens is advising users to inspect the gasket under the Glass Rod Sensor if an error code due to low vacuum is displayed, and contact Siemens Technical Support for a replacement gasket if required. Siemens will be inspecting the Glass Rod Sensor on all analysers during the next service visit to replace if necessary.
Siemens recommends discussing this notification 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
Investigations have confirmed that certain lots of non buffered formalin have had incorrect labelling placed on the bottles. the bottles have been labelled as 10% neutral buffered formalin, rather than non buffered formalin. this issue is unlikely to cause adverse health consequences.
Acción
Thermo Fisher is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 18/08/2016.
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
The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.
Acción
Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 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
Ortho clinical diagnostics (ortho) recently identified that under very specific conditions, the temperature in the microwell subsystem (included on other vitros systems) may potentially be out of range without the system properly alerting the operator. although the vitros 4600 system and vitros 5,1 fs system do not include a microwell subsystem, it utilises the same software as other vitros systems. ortho has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the microslide or microtip subsystems included on chemistry systems, based on e-connectivity data.In the low likelihood that the anomaly occurs (<1 in 14 million), it is possible to process samples outside of the proper temperature range where results will not be flagged with an “it” (incubator temperature) result code. this anomaly has never been known to result in a biased result, and it is not reasonable to expect that a biased result would ever occur due to the anomaly.
Acción
Ortho has determined that the anomaly is due to an error in the software code. The resolution is currently under development and will be provided in a future version of software.
Due to the low likelihood for this anomaly to occur, Ortho is not requiring users to monitor the temperature of their system. However, users may choose to verify that their system is within the proper temperature range. This action has been closed-out on 29/08/2016.
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 is an issue with the ahg control cells not testing as expected. it is giving very weak positive reactions when it should be giving a strong reaction when validating antiglobulin tests.Ih production has determined that the product was not formulated correctly, as the trial pool of the anti-rh sensitising reagent and the bulk were not made to the same strength due to operator error. this has resulted in the bulk anti-rh sensitising reagent being made 10 x weaker than the trial pool. this weak batch was used for formulating the ahg control cells.
Acción
The sponsor Seqirus is advising customers to inspect stock and quarantine all affected units prior to their return to the sponsor. The sponsor will arrange the replacement of the affected products or credit the account. This action has been clsoed-out on 29/08/2016.
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
This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.Cell 2 when tested against weak anti e controls (i.E. securacell) during pre-acceptance testing in biovue and grifols cat platforms, is giving weak or negative reactions and not the expected mid-strength reactions. however, testing in the bio-rad (diamed) cat platform is giving the expected result.There is a potential risk that undetected weak anti-e antibody using certain cat platforms could lead to delayed hemolytic transfusion reactions (dhtr) for the patient.
Acción
The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016.
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
Kawasumi laboratories inc. in japan has received 4 reports worldwide where the needle cannula of the a.V fistula set for haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
Acción
Terumo advises users to stop using the A.V Fistula set for Haemodialysis from the affected population. Customers are advised to quarantine and destroy all product in the affected population. This action has been closed-out on 31/08/2016.
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
Siemens healthcare diagnostics is conducting a recall for product correction for the advia chemistry halogen lamp (smn 10309448) in advia chemistry systems. siemens has identified specific lot numbers of the halogen lamp that may have a defect that could cause it to fail prematurely.The potential exists for a delay in testing if the halogen lamp fails prematurely. results are not impacted as the system will become inoperable when this issue occurs. the risk to health is low. siemens is not recommending a laboratory look back as a result of this issue.
Acción
The sponsor Siemens is advising users to inspect unused stock and discard affected units. The sponsor will replace the affected units. If the Halogen lamp currently installed in the system fails approximately 100 hours after installation, customers are to contact the sponsor for a replacement. This action has been closed-out on 24/05/2017.
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
An internal technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that oxoid antimicrobial susceptibility testing disc penicillin g (p1), ct0152b lot 1675623 may contain a small number of discs that produce variable results. not all of the lot is affected however our investigation identified that the size of the inhibition zone varied significantly with some discs producing larger than expected, unexpected or irregular zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
Acción
End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 22/08/2016.
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
This recall is due to the unexpected shortening of the optional ps500 battery on an iacs workstation critical care unit. the batteries were discharged early, even though the device was indicating an adequate battery state of charge. the devices generate a "battery low" alarm, followed by "battery flat". in exceptional cases, the "battery flat" alarm might be displayed too late, or not at all. after complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases. it has been discovered that the current design of the charging algorithm for the new ps500 batteries is not able to appropriately prevent premature battery ageing in all application scenarios.The unexpected loss of automatic ventilation functionality due to depleted battery requires immediate user intervention to prevent serious patient harm, including death. no patient injuries have been reported so far.
Acción
The sponsor Draeger is advising users not to use devices with the affected PS500 battery unit for patient transport until the firmware has been updated.
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 software related issue with the syngo x-workplace (s/w vd10e) and tabcard "4d" viewer application. when a volume is acquired with a ct scanner with a tilted gantry, the measurements displayed in the 4d tabcard can be incorrect, due to incorrect calculations in the multi-planar reformattings (mprs) of the volume. this might potentially result in the physician selecting a device with the wrong size (too small), which then needs to be exchanged. in the event that the device needs to be exchanged, it could lead to a medium term delay in a clinical procedure.
Acción
The sponsor Siemens will contact the affected customers to arrange for the installation of a software update which will eliminate the reported problem. Users are advised to load the MPR acquired at a CT scanner with tilted gantry into “viewing” application and perform 2d measurements there until the software update has been installed. This action has been closed-out on 29/08/2016.
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.
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
There may be a delay in delivery of pain medication when using epidural mode with patient bolus on sapphire multi-therapy & sapphire epidural pumps that have software v11.00 or lower installed. on these pumps, this delay can only occur if the user attempts to start the infusion without first opening the clamp.Under specific conditions, if a treatment that is programmed in epidural mode is started by the user without the user opening the clamp, the pump may not detect an occlusion. this resultant potential delay in therapy may happen, if, and only if, all of the following conditions occur concurrently:a. the clamp is left closed at the “start” of the treatment; andb. the treatment is set at epidural mode; andc. the programmed treatment is set to “bolus only”, i.E., the basal rate=0;this specific combination of conditions may only occur with pumps that have software v11.00 or lower. there is a potential risk of delay in the pain therapy.
Acción
Hospira is advising users to upgrade software on the affected devices. Additionally, Hospira is reminding users to ensure the clamp is open when starting an infusion. This action has been closed-out on 06/09/2016.