Medical Device Safety Notices

The Irish Medicines Board publishes notices relating to the safety and/or quality of Medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

To view electronic copies of these Safety Notices please click here.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to vigilance@imb.ie.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The IMB puts these notices on our website for information. A summary list of these notices are published by the IMB in the first week of the month.

If you have product that is impacted by these notices you may have already been contacted directly by the manufacturer. To find copies of these notices* please click here.

Note: The summary lists up until November 2010 includes all FSNs communicated to the IMB. From December 2010, the summary list only includes FSNs where the manufacturer has confirmed that the issue has an impact on the Irish market and cases where the impact on the Irish market is undetermined because the manufacturer has failed to confirm that there is no impact on the Irish market.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the IMB seek confirmation from the manufacturer that the required action has been completed.  Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer.  For example, difficulties in obtaining access to the device or in tracing the location of the device.  Users of the affected medical devices should review the relevant information and follow the guidance provided.

The document below provides details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Field Safety Notices - Outstanding Actions

*  Please note that the notices included in this listing may not be complete.  The listing only includes FSNs that have been notified to the IMB.