Field Safety Notice Summary Sheet - Outstanding Actions
04 February 2014
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.
FSN Summary Sheet - Outstanding Actions January 2014