A field safety corrective action is a corrective action taken by a manufacturer due to, for example, device malfunction and the associated risks for patients, users or other persons. The medical device manufacturer or its authorised representative must notify both the JAZMP and the device users about the field safety corrective actions by written communication.
A field safety corrective action is communicated to the users using a field safety notice. Field safety notices for the territory of the Republic of Slovenia must be issued in Slovenian.
It should be noted that the list of field safety notices may not be complete. If you receive a field safety notice that is not included in the monthly list, please notify us using the following electronic address: .
