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 problem has been detected with philips model epiq 7 ultrasound system v1.0 when using philips qlab a2dq software feature. it is possible to have erroneous ejection fraction (ef) measurements appear in the biplane analysis report page under certain conditions while using a2dq. the biplane analysis report page could display ap2 or ap4 edv/esv/ef measurements from a prior patient’s exam. erroneous measurement information in the biplane analysis report page could mistakenly influence patient care. this issue only occurs on software version 1.0 in a2dq during a live (frozen) image and only when a single biplane view is included in the exam. when both biplane views are present (ap2 and ap4) this issue does not occur.
Acción
Philips corrected this issue in Version 1.01 of the EPIQ 7 Ultrasound System. A Philips Field Service Engineer will be contacting customers to schedule the V1.01 upgrade to affected systems. Philips is providing temporary workaround instructions to prevent the failure mode from occurring until the systems are upgraded.
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
Beckman coulter has confirmed that some ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected. affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
Acción
Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary.
As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve is 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
The manufacturer, magstim has identified a manufacturing non-conformity on a single 9784-00, magstim 90mm high power coil. the nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. the failure mode would be such that a loud bang would be produced and the coil would cease to function. there could also be damage to the stimulator to which the coil was connected.
Acción
Medtel is requesting users to stop using the coils. Product can be returned to Medtel 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
Stryker spine has received reports that the hex tip of the xia 3 torque wrenches of an identified lot number subset have been fracturing during final tightening. the hex tip of the wrench is broken off and separated from the main tube.
Acción
Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the Xia 3 Torque Wrench. Unaffected replacement units will be provided.
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 investigations of the affected lot number indicate that the performance of this lot may change over time leading to an increased number of false positive results.
Acción
Alere is requesting their customers to discontinue and destroy all remaining affected lots. Alere is advising users to consult with their resident clinical expert or doctor, if they question any previously reported results.
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 investigation indicates that specific lots of check valves used in several locations within the lh 750 and lh 780 analysers may fail. this failure may result in air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line. there is a remote risk of reporting false high or false negative results for all parameters on control and patient samples if the backwash tank fails to refill after manual aspiration. there is also a risk for a leak of biohazardous waste if the check valve fails at the vacuum overflow tank waste line. this risk is limited to samples analysed using the manual aspiration mode.
Acción
Beckman Coulter is recommending users review manual mode sample results if the "Backwash Tank Not Full" error occurs for all samples obtained since the last acceptable QC run. Beckman Coulter is advising users to avoid physical contact with a possible leak and follow personal protective equipment (PPE) guidelines as recommended in the Instructions for Use (IFU). Beckman Coulter will be contacting all sites to arrange an on-site visit to inspect valves and replace any affected valves.
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
Mathys ltd bettlach has been notified of an incident in switzerland where the optimys opening broach broke intraoperatively and the fragment was left in the bone. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favour breakage in case of non-compliant usage.
Acción
Replacement products made of more suitable material are being manufactured and will be provided to customers as soon as they become available. In the interim, customers are reminded on the correct usage of the device according to the surgical technique.
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 investigation indicates that specific lots of check valves used in several locations within the dxh 800 and dxh 600 systems may fail. a failure may result in an air or liquid leak at the vcs waste chamber or probe waste chamber.
Acción
End users are advised that if they experience a "Vent/overflow chamber detected overflow" error message, the three samples prior to the error message must be reviewed. Physical contact with leaks should be avoided by continuing to use protective equipment.
A service representative will contact each customer to schedule an on-site visit for check valve inspection of any affected valves.
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
Carestream health australia has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios.This problem occurs infrequently and only when all of the following conditions are met:1) the version installed is v11.3.2 or v11.3.2.4 or v11.42) the exam type is from multi-slice modalities3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images.4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
Acción
Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol.
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 certain lots of the affected neurovascular products have incorrect product expiry dates printed on the packaging. all products are currently still within their validated expiry date, the earliest expiry date being april 2015.
Acción
Stryker is requesting users inspect stock and return affected stock to Stryker 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
Medtronic has identified that a small subset of 2090 programmers have an incorrect software configuration for the country in which that are physically located. when a programmer is manufactured, it is configured for the region in which it will be located. in this way, medtronic is able to differentiate the timing of software updates across different regions of the globe. through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured.
Acción
Medtronic is requesting users to return affected devices for re-configuration. Medtronic representative will contact customers to coordinate the servicing and return of the programmer.
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 b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under estimated in this situation and treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the off position.
Acción
GE Healthcare is providing users with work around instructions to follow until a software correction is 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
The manufacturer ethicon endo-surgery, has determined that the straight adjustable gastric band was unable to pass the internal test for 'force to close'. as a result surgeons may experience difficulty in locking the straight gastric band buckle during implantation. once the product is locked, the gastric band will remain in place and will function as intended.
Acción
JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future.
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 received a complaint indicating that the expiry date printed on the syringe blister packaging is the same as the manufacturing date (i.E. april 2013).
Acción
BD is advising customers of the correct expiry date for lot number 3085361 is April 2018.
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
Med-chem surgical has received reports of the affected batch of diathermy pencils ceasing to function during use.
Acción
Med-Chem Surgical is requesting their customers to inspect their stock and quarantine any units from batch 1303141. Recovery and replacement of stock will be arranged once customers confirm they are affected by the recall.
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 come to the attention of boston scientific that the packages of twister plus may not be fully sealed, affecting the sterility of the device. use of a retrieval device from a package with an open seal may impart a patient risk of infection.
Acción
Boston Scientific is advising users to segregate the affected product and return to Boston Scientific for 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
Stryker has received complaints associated with cracks and/or fractures of the ball impactor tip and rim impactor tip instruments. the potential hazards include;- cracked or fractured ball impactor tip/rim impactor tip- loose fragments form the ball impactor tip/rim impactor tip- insufficient locking strength of the mdm liner (ball impactor tip only).
Acción
Stryker is releasing updated surgical procedures and also updating the loan dockets, recommending the use of a slotted mallet to be used to impact the impactor handle, and emphasising that all tips should be inspected for deformation and cracks before 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
Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier has initiated recall of all lots of aequalis reversed ii and reversed fracture impactors (items number mwd021, mwd023, mwd024, mwd025). upon review of the event, tornier determined that a redesign of the instrumentation was warranted.This recall action was carried out prior to approval by the therapeutic goods administration.
Acción
In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.
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 possibility of packaging leakage for the tissue-guard family of products- vascu-guard, dura-guard, peri-guard, and supple peri-guard. these products are packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. the contents of the unopened, undamaged container are sterile. leakage can occur as a result of damage during shipment and can be identified by an unsealed container or by highly visible evidence of water damage to the packaging, instructions for use, box, label, and/or - surrounding products in the shipping container.
Acción
Baxter is requesting their customers to locate all affected product and return for 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
During a rad (radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. this malfunction occurs when the generator stops the tube power too late and therefore too much dose is applied during an acquisition. this may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode.
Acción
It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum time that unwanted radiation will continue. The exposure can be interrupted by the user at anytime by releasing the exposure button. Siemens has implemented a field modification that will resolve the issues. The Australian roll out of this field modification is planned for completion in Q4 2013. 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
A printing error has been identified on one unit of optease retrievable vena cava filter. the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. all lots of the cordis optease retrievable vena cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred.
Acción
Customers are requested to quarantine the affected product prior to returning to JJM.
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
After successful introduction of an optimised delivery system design, the device manufacturer angiomed has determined that the optimised lifestent solo vascular stent systems have a significantly lower incidence rate of partial stent deployment associated with their use compared to the original lifestent vascular stent system. the manufacturer, angiomed, has determined that due to the number of lifestent vascular stent system original design devices still available in consignment and customer inventory positions, and the improved performance of the lifestent solo vascular stent system optimized design, a recall action related to the original design product is warranted. this measure will provide customers and patients the lifestent solo optimized stent delivery system performance.
Acción
Customers are requested to inspect their stock and quarantine any product from the affected lots. Bard will arrange for the return and replacement of affected stock. No medical or surgical interventions and no monitoring measures are required for LifeStent Vascular Stents which have already been implanted, as the reported partial stent deployments occurred during the release of the stent from the delivery system.
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
While operating in pressure control ventilation - volume guarantee (pcv-vg) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.
Acción
GE Healthcare is providing users with work around instructions to follow until a software upgrade is provided to all customers by June 2014.
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 low but existing entrapment risk for a patient being treated of this bed while being under a bmi of 40. small, lightweight patients are at a greater risk of entrapment because their small physical dimensions may enhance their ability to fit into a gap, in whole or in part.
Acción
Arjohuntleigh is providing revised Instructions for Use (IFU) and additional labelling on the frame of the affected beds.
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
The manufacturer, q core, has received three similar reports from a customer, who experienced deviations from the duration of treatment, as programmed. the incidents occurred while using the multi step mode. while no patient injuries or deaths have been reported, the issue may result in incorrect therapy. specifically, the issue only occurs when the following conditions are met simultaneously:- multi-step mode is used, and- the pump is not plugged into an ac power outlet and is operating on battery power only, and- the pump backlight is turned off.The factory default for the backlight configuration in the sapphire multi therapy pump is on; therefore unless the pump backlight is turned off, the issue will not occur.
Acción
Q Core has developed a software solution (Rev09Ver08) to address the issue. Until the Sapphire Multi Therapy pumps have been updated with the new software, users are required to:
(i)Use the Sapphire Multi Therapy pump plugged into an AC power outlet; and/or
(ii)Use the Sapphire Multi Therapy pump with the backlight configuration set to ON or PARTIAL.
It is recommended to check all pumps that are in current operation in order to ensure correct setting of the backlight. Please note that in pumps configured with backlight OFF the screen will darken completely after 1 minute of screen inactivity. The pumps configured to have the backlight OFF require reconfiguration of the backlight setting to ON.