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
In november 2014, radiometer pacific notified customers (tga ref: rc-2014-rn-01201-i) that the ccrea results for qc decrease to below the lower acceptance limit within the lifetime of the crea membranes. the corrective action implemented at that time was to perform one quality control measurement every 24 hours using s7835 autocheck 6+, level 1 (944-094) to verify the ccrea performance. if the qc result was out of range, new crea a and crea b membranes had to be installed.Radiometer has now resolved the problem (starting with lot 557 and onwards) with narrowed specifications for the membrane material to reduce the diffusion rate through the membrane and has verified that the change brings the performance (drift and lifetime) back to the previous level.
Acción
For membrane units below Lot 557:
Continue to perform one quality control measurement every 24 hours using S7835 AutoCheck 6+, level 1 to verify the cCrea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed.
Alternatively, if you wish to return any remaining unused units of cCrea membrane from Lots below 557 please contact your local Radiometer Account Manager on 1800 247 254.
For membrane units of Lot 557 onwards:
You may return to your standard practice for running QC for the cCrea membranes. This action has been closed-out on 17/08/2016.
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
Some of these products may have a hole in the blister pack, which may compromise the sterility of the product inside the tray. invasive medical procedures conducted using non-sterile products could result in an infection for the patient. to date, there have been no reports of patient harm or infection attributed to this issue.
Acción
Customers are asked to check their inventory and place affected stock into quarantine. Culpan Medical will arrange to have quarantined stock collected. Unaffected products are available to replace any returned units. This action has been closed-out on 08/08/2016.
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
A small number of oximetry cables have been identified with crossed-internal wires.The effect on performance when these wires are crossed is that when a low spo2 value is measured, a high spo2 value would be displayed on the monitoring device. additionally, in the same oximetry cable, when a high spo2 value is measured, a low spo2 value would be displayed on the monitoring device.
Acción
Philips is providing instructions for hospitals to verify the performance of the oximetry cables. If the cables are not working as expected they are to be returned to Philips for replacement or refund. This action has been closed-out on 06/09/2016.
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
Cook medical has received 3 reports of products with the product label indicating the wire guide is curved (the letter “c” in the prefix tscmg- stands for curved), however actual product inside package is a straight wire guide.This observation was made prior to use of the product as the physician is able to see the wire is not curved. the instructions for use (ifu) state “upon removal from package, inspect the product to ensure no damage has occurred.”.
Acción
Hospitals are requested to immediately collect and return all unused affected products to Cook Medical for credit. This action has been closed-out on 12/08/2016.
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
Abbott point of care inc. (apoc) has determined that certain lots of i-stat pt/inr cartridges may generate a higher than typical number of pt/inr star outs, due to the internal quality system suppressing results if the analyser or cartridge does not meet certain internal specifications. there is a potential to delay the generation of patient results for pt/inr due to the star outs. when results are generated they are within the expected performance of the assay.
Acción
Cartridges can continue to be used for patient testing. If you repeatedly observe the condition where cartridges from the lots listed above display star outs, please contact Abbott Customer Support for your country and they will organise replacement of impacted stock. This action has been closed-out on 02/05/2017.
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
Due to a production fault in a specific production lot of the triple-focus x-ray tube assembly, there is a possibility that the "small focus" may fail. if this occurs, no further radiation release will be possible from this focus source. the "large focus" and "micro focus" will still be operational.
Acción
This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016.
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
Approximately 10% of users globally have reported to 3m that lava ultimate crowns de-bonded at a rate higher than their typical experience for crowns. the reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
Acción
3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016.
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 o-ring in the swivel wye connector was out of specification and causing leaks in some of the affected circuits supplied.
Acción
Koala Medical is requesting their customers to quarantine the affected batches. Koala Medical will arrange for the recovery and replacement of the devices. This action has been closed-out on 12/08/2016.
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 a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
Acción
Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. 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
It has been identified during the installation of neptune rovers that there is a potential for the rover’s diverter valve assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the neptune fresh water system. the diverter valve’s material combined with the heat-treating process has the potential to cause diverter valve corrosion when the rover is allowed to sit for a period of greater than 40 days.Only neptune 2 rovers out of rotation for greater than 40 days have the potential of exhibiting the failure. there is no risk to health as the neptune rover will be unable to dock either during installation or prior to surgery. rovers that are in active rotation are not likely to experience any issue related to this diverter valve material issue.
Acción
A Stryker Representative will contact affected facilities who have indicated they have Rovers which have not been used for over 40 days to schedule time to perform the diverter valve replacement. This action has been closed-out on 03/03/2016.
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
Brainlab has detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy: • large distance between reference array and region of interest • major changes of the camera position relative to the reference array during the procedure those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure. in the worst case scenario, these inaccuracies may cause an inaccurate display of instruments by the navigation system, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
Acción
Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrange for the installation of the update. This action is a follow-up to RC-2013-RN-00397-1.
This action has been closed-out on 05/12/2016.
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 manufacturer, intuitive surgical inc, has determined that the use of the getinge 88 turbo washer/disinfector in combination with getinge clean mis to reprocess instruments results in a higher chance of input disk breakage, rendering the instrument inoperable. the appendices in the reprocessing manuals incorrectly list the getinge 88 turbo washer/disinfector and the getinge clean mis combination for reprocessing instruments. the getinge combination of equipment and cleaning agents leaves a residual amount of detergent on the input disks resulting in disk breakage during sterilisation.
Acción
Device Technologies Australia (DTA) is requesting the customers to discontinue the use of the Getinge 88 Turbo Washer/Disinfector with Getinge Clean MIS for reprocessing da Vinci Xi instruments. DTA is suggesting alternative reprocessing methods. DTA is also instructing the customers to inspect the input disks of the Endowrist Instruments and identify any broken disks. Device Technologies representative will contact the customer to arrange the returns. This action has been closed-out on 10/08/2016.
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
Smith & nephew surgical pty ltd. has initiated a recall of arthrocare corporation procise ez view with integrated cable wands, lot 1093290, due to a manufacturing inspection issue. affected lot of these devices have been released without meeting the dielectric specifications. in the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. this created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. to date there have been no reported adverse events related to this issue.
Acción
Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016.
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 affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification whichcould result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment.
Acción
Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016.
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
American medical systems (ams) has determined that the validation data related to cleaning instructions and sterilisation methods and the methods defined in instructions for use (ifu) do not meet the new guidance on qualifying reusable products.
Acción
AMS is requesting the return of all unused inventory in the field. If the inventory has been used, and has not been discarded, AMS is requesting that the customers discard the devices or return the used device to AMS directly. AMS will be extending a credit to the customers for the purchase price.
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 by the manufacturer showed that one dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
Acción
Nobel Biocare is requesting their customers to cease using the device and to return it to a Nobel Biocare subsidiary and receive a replacement instrument. If the affected instrument is a part of a kit, a Nobel Biocare Representative will contact the customer directly. This action has been closed-out on 03/03/2016.
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 spot film device (sfd)/ intelligent digital device (idd) safety mechanism installed on the above systems may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1” (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.
Acción
GE Healthcare will correct all affected products. A GE Healthcare representative will contact you to arrange for the correction.
The system can continue to be used provided end users:
- Perform preventative maintenance in accordance with your product labeling. This includes inspection of the counterweight cables and pulleys every 6 month, and replacement of the counterweight cables every four years.
- Set the manual Myelographic stop on the fluoroscopy carriage during exams. This action has been closed-out on 05/08/2016.
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
Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90r probe. the investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. in each event a small piece from the distal end of the alumina ceramic broke off. the geometry of this type of crack differs from those normally observed by serfas probes.
Acción
Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.
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
Ge healthcare has become aware of a reported incident where a monitor fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
Acción
A GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, users are advised to perform a visual check before and after each use for the presence of the four (4) mounting screws. Check the secureness of these screws by hand. If these screws are present and secure, users may continue use of the system.
If any of these screws are missing or can easily be turned by hand, follow the precautions below before continuing use with the monitor(s).
- Position the monitor suspension in the most frequently used position and limit further movement as much as possible.
- Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position.
- Contact the GE Healthcare representative to inform them of any loose or missing screws. This action has been closed-out on 17/08/2016.
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
Wand hand piece model wa-2050-305 was packaged (pouched) and boxed as a wand sta hand piece model sta-5050-305. although the function of the hand pieces are identical, these hand pieces are used in two different instruments and they will only attach into the correct instrument.
Acción
Milestone is requesting the customers to inspect the inventory of the Wand Handpieces by looking at the cartridge holder locking tab without opening the sterile pouch. If any mislabelled handpieces are identified, Milestone is requesting the customers to contact Milestone Customer Service to obtain return authorisation and / or replacement of the handpieces. Milestone is also instructing the customers that they can also return the entire quantity of the affected STA Handpieces. 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
An internal investigation identified a shift of the ct values of lnternal control (ic1 w0, internal control with water) inside and outside the limit of specifications. the investigations performed by r&d; with ref. 71-020 lot 1002978600 showed that ct values results on the extraction control (ic1w0) with ct value close to the specification of validity (32 ct) or just above this specification. the ct shift values may be observed on a positive sample without impacting the limit of detection.
Acción
Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.
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 instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the qbc.
Acción
Philips is reiterating the warnings in the IFU regarding positioning the cables and leads. A sleeve is being developed that will be applied to the cable on the SENSE Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating.
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
Handicare received two complaints stating that while demonstrating the function of returnbelt, when exposed to high load, the strap ripped at the heat welded seam. this action was undertaken prior to notifying the tga.
Acción
Handicare AB requested all belts with the affected lot number to be returned. Handicare AB through Active Medical is refunding the amount paid.
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 targeting jig mast is separating from the jig boom. any separation will impact alignment and can affect the ability to fixate the screws.There has been no impact to a patient to-date; however, a design change to the product is necessary.
Acción
Tornier is developing a design change for the jig. Once the design change has been completed Tornier will arrange for the collection and replacement of the faulty devices. In the interim, Tornier has provided inspection instructions to ensure that faulty devices are not used in surgery.
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 xl+ software and hardware issues have been identified:software:the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in aed mode. hardware:the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm.
Acción
A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software and hardware upgrades. In the interim, users can continue to use XL+ prior to receiving the software and hardware upgrades; however they should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits any of these issues.