Manufacturers should inform users of (medical or in vitro diagnostic) devices if they identify a safety issue with their device. Users are informed by means of a field safety notification (FSN / Urgent FSN).
Actions proposed by manufacturers in field safety notifications may include: updated instructions for safe use of the device, recall of the device affected by the safety issue, etc.
If you have acquired a device affected by a safety issue, please read the related field safety notification carefully and follow the manufacturer’s instructions contained therein. For questions related to the manufacturer’s instructions, please contact the issuer of the field safety notification directly.
SUMMARY OF FIELD SAFETY NOTIFICATIONS
Summary of field safety notifications / AUGUST 2024
Summary of field safety notifications / JULY 2024
Summary of field safety notifications / JUNE 2024
Summary of field safety notifications / MAY 2024