A Field Safety Notice (FSN) is a letter in which the device manufacturer informs users of corrective actions taken in the field to ensure the safety of the devices (field safety corrective action).
The FSN provides information on the identification of the affected devices and the reasons for the field safety corrective action. The FSN describes the risks to patients, users or others affected by the problem. It also provides the measures to be taken by users to reduce or eliminate the risk.
Most FSNs are intended for professional users (doctors, pharmacists, etc.). Patients who, after reading this information, have questions about the impact of the notified risks are invited to contact a doctor or pharmacist.
Please note that if the use of the device is exclusively intended exclusively for healthcare professionals, the FSNs are only available in English (in accordance with art. 65 of the law of 22 December 2020 on medical devices and art. 64 of the law of 15 June 2022 on in-vitro diagnostic medical devices).
The content of the FSN is the responsibility of the device manufacturer.
Below, you will find the link to the FSNs concerning for Belgium. This list is updated on a weekly basis.
If you receive a FSN from a manufacturer that is not on the list, please let us know by e-mail: vigilance.meddev@afmps.be.