Manufacturers need to inform device users (users of medical or in vitro diagnostic medical devices) if they identify, on their device, a safety issue. User information is carried out through a field safety notification (FSN / urgent FSN).
The actions proposed by manufacturers in field safety notifications can be: updated instructions for the safe use of the device, recalling the device affected by the safety issue, etc.
If you have come into possession of a device affected by a safety issue, carefully read the related field safety notification and follow the manufacturer’s instructions included. For questions about the manufacturer’s instructions, please contact the issuer of the field safety notification directly.
SUMMARY OF FIELD SAFETY NOTIFICATIONS
Summary of field safety notifications / JUNE 2025
Summary of field safety notifications / MAY 2025
Summary of field safety notifications / APRIL 2025
Summary of field safety notifications / MARCH 2025
Summary of field safety notifications / FEBRUARY 2025
Summary of field safety notifications / JANUARY 2025
Summary of field safety notifications / DECEMBER 2024
Summary of field safety notifications / NOVEMBER 2024
Summary of field safety notifications / OCTOBER 2024
Summary of field safety notifications / SEPTEMBER 2024
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