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
Based on post market surveillance activities, carl zeiss has determined that in certain devices there is an increased probability of failure of the power supply on/off switch, and surface corrosion of the mirror which changes the direction of the light projection. there is no potential health hazard and the probability of injury is extremely unlikely. in a worst case scenario, a burning smell may result from a thermal event at the power supply on/off switch. issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. the slit projection may be slightly darker and more diffused.
Acción
Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.
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
Microline surgical has received customer reports that the heat-shrink insulation tube of renew reusable scissor, grasper and dissector tips may split during autoclave sterilisation/re-sterilisation. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip.
Acción
1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession.
2. A CR Kennedy Representative will contact customers to:
a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility.
b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable).
c. Organise a credit for all product returns to customer accounts.
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
Thermo fisher received an internal technical investigation confirming that a specific lot of tm0268 gc sugar set may provide atypical performance when used with some strains of neisseria species. false negative results may be seen with the glucose reaction with some strains. continued use of this lot may result in incorrect results reporting or a delay to results reporting due to additional testing requirements.
Acción
1. Inspect and remove from further use all units from the affected batch number, then complete the supplied Facsimile Reply Form and return for a credit note to be issued.
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 owi has received complaints about fragments of adhesive detaching from the inside of the working channel of cystoscopy bridges. chipping, cracking and delamination of the adhesive may occur when inserting an instrument through the working channel. in the rare occurrence that an adhesive fragment may fall in to the patient it can be flushed out with irrigation fluid or passed naturally. the retrieval of large adhesive fragments may require additional surgical treatment and extended anaesthesia. to date, there have been no reports of adverse events or patient injury related to this issue worldwide.
Acción
1. Users with affected lots should continue to use existing Cystoscopy Bridges until replacements are obtained.
2. Complete and return the supplied reply form to Olympus.
3. Check the delivery details and number of affected devices listed in the customer letter that need replacing from Olympus, and contact them on 1300 657 699 with any changes.
4. Upon receipt of the replacement Cystoscopy Bridges from Olympus dispose the affected bridges and use the replacement devices.
5. Users who have distributed or transferred any of the affected products to other facilities should forward this recall notice and please notify Olympus so that they can follow up with that facility directly.
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
Philips has identified when using the downscale option, the measurements performed with the allura r9 or azurion r1.1 systems (using qa basic measurement tool) will not be correctly exported to the external dicom destination. the difference between the original & exported measurements can vary, and the distance value after export is factor 1 to 4 smaller than the original. the difference will depend on the acquired image & used archive settings. if the measurement is re-performed at the external dicom destination, the result will also be incorrect unless a recalibration of the image is executed. if these exported downscaled images are used during/in preparation of a procedure, the incorrect measurement values could result in the selection of an incorrectly sized device. the same applies if a measurement is re-performed at the external dicom destination without executing a recalibration of the image.To date philips is not aware of any injuries that may have occurred due to this issue.
Acción
1. The Downscale option should be disabled in all Export protocols until Philips corrects this issue.
2. Distribute the notice to all users of the device.
3. Complete the supplied response form and return it to Philips.
4. The problem will be resolved by a software update, which is expected to be available by the end of 2017.
5. Philips representatives will notify users when the software update is available for installation.
6. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Becton dickinson (bd) has identified punctures in the blister packaging detected during the packaging process for specific lots of plastic cannula – 11 gauge.A breach in the sterile barrier has the potential to render the device non-sterile. it is possible end users may not detect the pin holes, thus utilising impacted product clinically. this could result in harm to patients especially when immunocompromised.In association with this recall, bd has decided to discontinue catalogue number: 9391-0200.To date, bd is not aware of any report of injury attributed to this defect in australia.
Acción
1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge).
2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification.
3. Becton Dickinson is requesting that any impacted inventory be returned.
4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.
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 regular qa inspection, parker healthcare noticed an irregularity in the expandable tubing of specific tube/mask breathing circuit single-use connectors (disposable catheter mounts). to date, no injury or illness has been reported.
Acción
1. Complete and return the supplied acknowledgement form. If any of the affected products have been transferred from your facility to another, immediately inform other supplied facilities of this Recall.
2. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. Returned stock will be replaced with unaffected batches at no cost.
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 identified that st-segments in a 12-lead ecg may become distorted and the st-value may be inaccurate when an affected monitor automatically activates ecg filtering in the event that a “ecg check cable” or “ecg noisy elec xx” inop condition is triggered and displayed. these inops are triggered when the monitor detects a low impedance between ecg lead wires and the cable shield in the lead set, which can be caused by mechanical damage or fluid ingress.Distortions on the st-segment and associated numerics can contribute to a misdiagnosis or misinterpretation, which can cause a delayed or an incorrect treatment.
Acción
Users are to complete and return the supplied acknowledgment form.
Until the software is updated, users are to ensure that the “ECG Check Cable” or “ECG Noisy Elec xx” INOP is actioned following the instructions in the corresponding IFU.
A Philips Healthcare representative will contact customers with affected devices to arrange a software update to correct the issue.
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
Teleflex medical australia has been advised by the manufacturer sage products llc that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. the affects all oral care products containing solutions manufactured by the third party supplier. the affected products were distributed between july 2015 and august 2017.
Acción
1. Discontinue use and/or further distribution of the affected lots.
2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com
3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form.
4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have 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
Imdsoft has received a complaint stating that there was a malfunction with the metavision icu system that resulted in specific medication doses missing in multiple patient files. after an analysis of this complaint, imdsoft determined that:- one patient did not receive some specific planned doses that were prescribed. the problem in the software also identified to occur for few other patients, but in their case no actual doses were skipped. no grave patient outcomes have been reported.- the cause was found to be a software malfunction in the metavision code which affected the behaviour of the order management driver (omd) - part of the metavision icu medication management module. the software malfunction resulted in an unnoticed omd failure which did not create specific medication doses of medication orders exceeded the horizon of 7 days per treatment plan. this led to the non-provision of specific medication doses to several patients.
Acción
1. Complete the supplied Customer Response and return it by email to FSN@imd-soft.com.
2. Contact iMDsoft Customer Support on 1800 240 919 to arrange a software upgrade 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
Taleb medical has received a customer complaint relating an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. an analysis has identified that after two and a half years, the battery fuel gauge may indicate a higher battery charge as to what is actually available. the technical failure 444001 ”low battery” high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.When batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode.
Acción
1. The operator or service personnel should make themselves familiar with the batteries’ date of installation and manufacturing date and react in time if the battery is more than two years in operation or maximum three years from the manufacturing date.
2. The battery’s manufacture date is engraved on the top of the battery connector (see supplied letter for details).
a. Any battery in operation for more than two years prior to the actual date should be replaced.
b. If the battery is less than two years old attach a label stating the manufacturing date or the commissioning date of the battery (if known) manually on the battery or the ventilator which contains this battery and check it periodically against the current date.
c. Slide the battery back into slot until it clicks and close the battery door.
3. Complete and the supplied customer acknowledgement form and return to Taleb,
4. Taleb will arrange for the replacement of affected batteries.
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 that very occasionally, the coaguchek® xs plus meter or coaguchek® xs pro meter may power off when removed from the external power supply or handheld base unit if using the rechargeable handheld battery pack. due to a software error in the handheld battery pack the meter may sporadically go into an error mode, with the meter subsequently powering off. this issue affects only those battery packs in the range serial number uu100000 to uu109415 (batch number 05604041 to 05705151) with software revision 20 (please note: the revision number is printed on the outer package of the handheld battery pack; it is not visible on the battery pack itself). if this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. the meter will then work correctly after reboot. alternatively, if not connected to the lis, the meter may be used with 4 aa batteries and the standard battery compartment cover.
Acción
1. If this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. The meter will then work correctly after reboot. Alternatively, if not connected to the LIS, the meter may be used with 4 AA batteries and the standard battery compartment cover.
2. Contact Roche Diagnostics Australia via the call centre on 1800 645 619 to arrange for a replacement battery pack, quoting the reference number QN-CPS-2017-174.
3. Retain this letter in a prominent place in your laboratory for at least one month.
4. Acknowledge receipt of the notification, using the supplied link or reply directly to Roche Diagnostics Australia by email at australia.qra@roche.com to confirm your receipt of this notification.
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 become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. over-delivery of insulin can cause hypoglycaemia and in extreme cases, death. medtronic has received reports of hypoglycaemia requiring medical intervention potentially related to this issue. out of the millions of infusion sets sold each year, the reported incident rate requiring medical assistance related to this issue is less than 0.00005%. there have been no reports of death related to this issue.An investigation by medtronic has shown this issue can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the reservoir or inside the tubing connector which then could prevent the infusion set from working properly.
Acción
For patients:
1. Users and HCPs with affected lot numbers (as confirmed with Medtronic using the dedicated webpage https://checklots.medtronicdiabetes.com
or Global Help Line 1800 777 808) are to cease using the sets and, in the absence of unaffected alternatives, follow the steps contained in the supplied letter.
Medtronic will replace the affected sets free of charge.
2. Cut out the bar codes on the boxes of recalled infusion sets (as per supplied picture) and return the bar codes in the reply paid envelopes that will be sent out with the new infusion sets.
3. Users are to discard, not return, the affected sets.
4. Customers are also requested to complete and sign the supplied Acknowledgment Form, and return as directed to Medtronic Australasia.
For further information, please see https://www.tga.gov.au/alert/medtronic-minimed-infusion-sets
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 has become aware of instances in which the elective replacement indicator (eri) in some devices has triggered earlier than intended. in these cases, the eri alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (ipg). eri alerts estimate battery life based on programmed device parameters and patient usage and are unique to each patient. importantly, please note that this issue is an error in software calculation and is not an indication of the devices’ actual battery performance. currently, all implanted ipgs within the infinity and proclaim families are affected by this issue.
Acción
1. If an ERI message is displayed on the PC, contact Abbott to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps supplied in the letter.
2. Follow-up communication from Abbott will be provided in order to make appropriate decisions. Either by:
- ERI is valid at this time for this device, follow existing information provided by IFU and CP for the elective replacement window for this device.
- The device has the appropriate level of battery voltage to provide the existing therapy until the next assessment, which should occur no later than March 2018. During this period, the ERI message will be displayed on the PC at the start of each session and may be dismissed.
3. Abbott will deploy a software upgrade that addresses the errors in calculation causing the inappropriate ERI message. Notification of the availability of this software update will occur through the Apple Public App Store for the PC and through the SJM App Catalogue for the CP.
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
Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. the top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. the consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the us fda, 3 serious injuries occurred (2 broken bones and 1 laceration).
Acción
Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction.
For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-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
Siemens has identified an issue whereby in the application “dsa roadmap” the artis system's intended behaviour is to reject the stored vesselmap from previously acquired dsa if the patient table was moved during the roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses it for the further roadmap workflow steps. depending on the amount of table movement which was applied during the roadmap workflow, the dsa vesselmap may be overlaid as vessel tree at a position which does not fulfil siemens' requirements for accuracy.If the displacement of the vessel tree is large, it may be recognised by the user. however, if the displacement is either slight or at an unfavourable plane, the user may rely on incorrect visualisation of the catheter relative to the vesselmap.
Acción
1. The software in affected systems will be updated to correct the issue.
2. Users are to return the supplied acknowledgement form.
3. If the device is no longer in their possession forward the notice to the new owners.
4. Siemens will contact users to arrange a time to perform the software upgrade.
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, part of thermo fisher scientific, has confirmed that the concentration of antibiotic in thermoscientific oxoid caz10 ceftazidime, ct1629b (specific lots) may decrease over shelf life if not stored frozen. specifically, antibiotic degradation has been identified in product stored at 8°c between 2 and 3 years of shelf life. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for ceftazimide.
Acción
1. Users are to inspect stocks and remove from further use all units from the nominated batch number, then complete the supplied Facsimile Reply Form a for a credit note to be issued.
2. Complete the supplied facsimile Reply Form even if there is no remaining stock subject to recall, so as to reconcile this process.
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 oculentis has identified possible sporadic opacification of the intraocular lens (iol). studies conducted for oculentis have indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the iol. although the cause of iol opacification is multifactorial, remnants could make the iol under certain conditions more prone to opacification. the opacification may compromise the optical transparency of the iol in time, potentially leading to a slow reduction in the patient's visual acuity.
Acción
1. For on-shelf units, users are to quarantine all affected stock, then complete and return the attached reply form fax to acknowledge receipt of this notice and advise your quantity of affected stock.
2. For implanted units there is no need for explanting or review of patients where the lens has been implanted.
3. In some cases, postoperative opacification of the IOL may present biomicroscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness.
4. IOL exchange is the only recommended treatment for postoperative opacification if the visual acuity is compromised in view of the patient's individual conditions and needs.
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
Radiometer has recently become aware that the internal temperature in the aqt90 flex analyser under worst case conditions may slightly exceed acceptable storage conditions for aqt90 flex on-board test cartridges.Please note that if the aqt90 is exposed to temperatures above the new limit, but still within the old limits, the cartridges are still safe to use. the specifications are only affected with a few % and this is below any clinical significance. no action is required regarding the cartridge.To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the aqt90 flex analyser has been adjusted to 30°c/86.0°f (down from 32°c/89.6°f).
Acción
1. To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 FLEX Analyser has been adjusted to 30°C (down from 32°C).
2. For users:
a. If the ambient temperature is above 30°C r reduce it to below 30°C or move the analyser to another location that is below 30°C
b.Complete and return the supplied Customer Reply form, within 7 days from receipt, to acknowledge this notification and implementation of the required actions.
c. If you are not the end user of the affected product please ensure that this letter is distributed to the final end user.
3. Radiometer will contact users to arrange a suitable time for a Radiometer representative to install a software upgrade V8.9.613.0 or higher. This software upgrade will reduce the heat generated internally and distribute the heat generated more evenly.
4. Users will also be provided with a revised copy of the Instructions For Use (IFU).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Arjo huntleigh has received customer complaints regarding the failure of gas spring (damper index no. 828.760) which did not support the safety sides properly. as a result, when safety sides are being lowered, the dampers do not slow down the movement of the side rail. in these circumstances, the dampers do not provide the correct distance between panels and the frame of the bed to ensure no entrapment of fingers.
Acción
ArjoHuntleigh will be in contact with users to arrange replacement of affected gas dampeners. In the interim, users are advised to refer to the IFU for details regarding processes for safe side rail lowering, including steps that the rail should be held until completely lowered.
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 biosense webster has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for two specific lots of thermocool brand catheters. alert 402 implies a ‘map: magnetic distortion’ when connected to carto 3 system. magnetic distortion may result in inaccurate catheter tip location information on the carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy. severe complications (e.G. av block, vascular injury, cardiac perforation) are highly unlikely but may occur due to the physician selecting higher than required power settings for a given anatomical area.Whilst there have been no reports of adverse events in australia, one adverse event of pericardial effusion requiring pericardiocentesis with no further patient consequences was reported internationally, and was deemed to be potentially associated with this issue.
Acción
1. Users should immediately inspect the device(s) in possession to determine if they hold affected product, if so quarantine this product prior to returning it to J&J; Medical.
2. Complete and return the supplied acknowledgement form, even if no affected product is present, as directed.
3. Return any affected product within 30 business days, by contacting JJM Customer Service on 1800 252 194.
4. Forward this notice to relevant personnel. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).
5. Maintain awareness of this notice.
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 recently come to starkey laboratories' attention that specific surflink media and surflink media 2 accessories may be operating outside their permissible frequency band (915-928 mhz), and may cause interference with mobile towers (operating in the frequency band 902-915 mhz). any potential interference to mobile towers does not cause any interference or disruption to the accessories themselves. that is, the accessories continue to fully function/operate even though they may operate outside the frequency band 915-928 mhz.
Acción
1. Retailers are to quarantine affected stock then complete and return the supplied acknowledgment form.
2. Affected units should be returned as directed to Starkey Laboratories Australia.
3. Retailers are requested to forward the supplied letter to customers along with a partially-completed acknowledgement form for the customers actioning.
4. End-users should complete the supplied Recall for product Correction form, then return the accessory (not the hearing aid) to Starkey directly (using the prepaid bag), or return the accessory to the clinic where it was purchased.
5. Starkey will update the firmware and return the units to customers.
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
Boston scientific has identified specific auriga xl 4007 laser consoles have been produced with the incorrect laser warning label applied to the console. the labels on the affected consoles provide incorrect information regarding the maximum power (p) and the wavelength (?) actually emitted by the console. the two potentially impacted elements related to the laser warning label being incorrect are: the selection/ordering of laser protection goggles and the arrangement or ‘setup' of the laser use area.
Acción
A Boston Scientific Certified Field Service Engineer (FSE) will replace the console’s Laser Warning Label with the correct Label. Users are advised to continue to follow the use and room setup instructions per Auriga XL User Manual (91043397). No further action is required by the users prior to the FSE visit.