"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
The latest test results confirm no evidence of genotoxicity or chemical toxicity of the filler material in breast implants manufactured by the french company poly implant prothese (pip).
Action
The IMB recommends that: Implanting surgeons / implanting centres
1. Ensure that all patients who were implanted with PIP silicone filled implants are advised of the content of this safety notice and the previous safety notice that was issued by IMB, Safety notice SN2010(13).
2. Highlight the key findings to the patient:
• Test results show no evidence of genotoxicity or chemical toxicity of the filler material in the implants.
• Mechanical testing of the implant shell carried out by AFSSAPS confirmed that there may be
an increased risk of rupture.
GPs
Advise patients who are concerned about their PIP implants to consult their implanting surgeon/ implanting centres.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Non-compliant acu-life dosage spoons and acu-life dosage droppers have been provided to pharmacy outlets in ireland. these dosage spoons and dosage droppers are not appropriately ce marked. although they carry the ce mark, the ce mark is not accompanied by a four digit notified body number, which confirms that the measuring function aspect of the medical device has been reviewed and certified by a notified body, as required by the medical devices legislation.
Action
Advice for Pharmacies Pharmacies and retailers should examine their stock to determine if they have any ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.
If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Atlantico Systems immediately to obtain further instruction and guidance.
Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:
(a) Do not carry the CE mark
(b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number Advice for Consumers
Consumers should check their dosage spoons and/or dosage droppers to determine if their device is branded ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.
If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Non-compliant patient monitors cms7000 manufactured by contec medical systems have been supplied to customers in ireland. these monitors do not bear the ce mark as required by the medical device legislation.
Action
• Check if you have these devices in your institution.
• Examine the devices to confirm that they are CE marked.
• If the device or the User Manual does not bear the CE mark, please contact the manufacturer or your supplier. The manufacturer or supplier will provide details of the necessary actions required.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Philips respironics is aware that a small number of millennium oxygen concentrators on the irish market may not yet have received a capacitor upgrade. the potentially affected population was manufactured between july 2003 and august 2004.
Action
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Philips Respironics Millennium Concentrators.
3) Determine if you / your institution has devices affected by this issue.
4) Ensure that corrective action is completed on all affected devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Non-compliant medical devices manufactured by contec medical systems have been supplied to customers in ireland. these devices do not bear the ce mark as required by the medical device legislation.
Action
• Check if you have these devices in your institution.
• Examine the devices to confirm that they are CE marked.
• If the device or the User Manual does not bear the CE mark, please contact the manufacturer or your supplier. The manufacturer or supplier will provide details of the necessary actions required.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Non-compliant explorer loop 4 wheeled rollators have been supplied to the irish market. these rollators are not ce marked, as required by the medical devices legislation.
Action
Consumers should check their rollators to determine if their device is branded an Explorer Loop 4 Wheeled Rollator.
If you find that you have one of these products, discontinue use immediately and contact Murray’s Medical to obtain an alternative product.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Non-compliant ezy dose baby care kits, ezy dose pacifier syringe nursers, ezy dose medicine spoons and flents paediatric urine collectors have been provided to pharmacy outlets in ireland. these dosage products are not ce marked.
Action
Advice for Pharmacies
Pharmacies should examine their stock to determine if they have any Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons and Flents Paediatric Urine Collectors.
If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Apothecary Products Inc. immediately to obtain further instruction and guidance.
Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:
(a) Do not carry the CE mark
(b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number
Advice for Consumers
Consumers should check their medicine feeders to determine if their device is branded Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons and Flents Paediatric Urine Collectors.
If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies within the harmony la, lc 500 and la 700 surgical lighting and media systems.
Action
The IMB advise that you:
• Check if you have these devices in your institution.
• If you have any of these identified devices in your institution, contact ALLPHAR SERVICES to arrange an upgrade of the lamp housing assembly.
• Ensure that you adhere to the manufacturer’s Operator Manual for use and maintenance of the product.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Unomedical a/s has become aware that in certain sterile urine drainage bags, there is potential that the connector between the catheter and bag may be blocked.
Action
The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA).
The IMB advises that users:
• Follow the manufacturer’s recommendations as outlined in the attached FSN.
• Identify the affected devices in your facility and contact the manufacturer to arrange for return.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Dentsply has become aware that certain lots of dycal may exhibit faster setting times than is normal for these products.
Action
DENTSPLY has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, O’Neill Dental Ltd., has ceased trading and there are no customer records available to assist traceability.
The IMB advises that users:
• Identify the affected devices in your facility.
• If you have affected devices, follow the manufacturer’s recommendations as outlined in the attached FSN and contact DENTSPLY to arrange for return
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.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Linet has become aware that certain bedframes are susceptible to developing cracked or damaged welds in one particular area of the bedframe.
Action
Linet has confirmed that this issue is confined to bedframes manufactured up to December 2005 (see FSN for affected serial numbers). To date, Linet has been unable to obtain full traceability for affected devices potentially distributed in Ireland.
The IMB advises that users:
• Identify the affected devices in your facility.
• If you have affected devices, follow the manufacturer’s recommendations, as outlined in the attached FSN, and contact Linet to arrange for modification.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Stolen non-sterile assut sutures assucryl and silk surgical sutures are labelled as “sterile”.
Action
The IMB advises that you:
• Check your inventory for the affected product.
• Monitor all incoming shipments for the affected product.
• If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Assut Medical Sàrl.
• If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Park house healthcare has issued a field safety notice (fsn) to notify users of the availability of an updated guide to correct mattress usage.
Action
Park House Healthcare issued a FSN and copy of the updated guide to customers who purchased mattresses within the time period 2005 – 2009.
The Irish Medicines Board (IMB) advises that users:
• Identify the devices in your facility, which are within the scope of this field safety corrective action (FSCA).
• If you have devices affected by this FSCA, follow the manufacturer’s recommendations, as outlined in the attached FSN.
• Maintain awareness of the updated guide within your facility and return the fax back form to Park House Healthcare, or your distributor, if you have not already done so
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Hill-rom is aware that a number of mobile patient lifts on the irish market may not yet have received an ‘outer tube’ accessory, which will prevent the actuator from collapsing in the event that it should malfunction.
Action
Hill-Rom has been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected mobile patient lifts.
3. Determine if you / your institution have medical devices affected by this issue.
4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that corrective action is completed on all affected medical devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
In august 2007, invacare changed the method of mounting the castor assembly to the sideframe. the thread length on the bolts used to mount the castors were found to be insufficient to guarantee that the bolts can be correctly tightened. loose bolts could potentially cause the sudden failure of one or both of the castor housing bolts, and the possibility of a fall from the wheelchair which could result in injury to the user.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected wheelchairs.
3. If you / your institution have affected wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Arjohuntleigh is aware of an issue with the contoura® 880 series hospital bed frames, whereby the cpr release arm on the backrest actuator could break during use and render the emergency cpr function inoperable.
Action
ArjoHuntleigh have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected bed frames.
3. If your institution has affected medical devices, please contact ArjoHuntleigh to arrange to carry out the required modification to the bed frame.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Invacare issued a field safety notice informing their customers of an update to transportation information provided in the user manual for the storm3 and typhoon range power wheelchairs. users of storm3 and typhoon range power wheelchairs should read the attached invacare field safety notice to determine if this information may have an impact on their transportation requirements.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected power wheelchairs.
3. If you / your institution have affected power wheelchairs, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Marus has become aware that the lens heat (bulb) shield (birdcage) on the marus luxstar dental lights, model ol1000, may potentially fall off the dental light if not properly installed after replacing the light bulb, or if not properly maintained.
Action
Marus has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, Dacus Dental, has ceased trading. The serial numbers of the devices provided to Dacus Dental are 4714B and 165569B.
The IMB advises that users:
• Identify the affected devices in your facility.
• Ensure the appropriate personnel are made aware of this notice.
• If you (or your facility) have affected devices, follow the recommendations outlined in the attached Field Safety Notice and contact Marus to obtain the self-installation kit.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Invacare have updated their instructions for use for the reliant lifter 100 / 150 / 200 / 250. the operating instruction in previous revisions of the user manual may have been misleading; in particular the guidance, given in some issues, on the appropriate use of the brakes when lifting the patient was incorrect and the instructions did not make adequate reference to taking caution when moving the hoist on uneven, rough surfaces and carpeted areas.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected lifters.
3. If you / your institution have affected lifters, follow the manufacturer’s recommendations as outlined in the attached field safety notice.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
Corona medical bed side rails – 1025, 1031 & sp 1027 range are not compliant with the dimensional requirements of the applicable standards, which defines the minimum size and / or maximum areas with risk of trapping in an adult bed for medical use. these side rails require replacement.
Action
Corona Medical and MMS Medical have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected side rails.
3. Determine if you / your institution have medical devices affected by this issue.
4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that corrective action is completed on all affected medical devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
It has come to invacare’s attention that the countersunk head screws in the base of the birdie lifter could potentially come loose. this can lead to breakage of the screw. if the screw breaks, the ‘leg’ of the base can detach and lead to a collapse of the lifter which may result in injury to the user.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected lifters
3. If you / your institution have affected lifters follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
In january 2010, invacare revised the instructions for use for action 3 and action 4 manual wheelchairs for various safety related aspects.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Ensure users receive a copy of the revised IFU.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notes supplémentaires dans les données
Cause
It has come to sunrise medical’s attention through post-market surveillance activities that a small number of upper frame tubes that support the backrest have failed on the quickie neon swing-away wheelchair. there is the potential for frames to fail and users could potentially fall backwards resulting in serious injury.
Action
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected wheelchairs.
3. If you / your institution have affected wheelchairs, please follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that the corrective action is completed on all affected medical devices.