A so-called “field safety notice” (FSN, Field Safety Notice) is sent by manufacturers to alert all users of affected products to important safety measures that must be followed.
It can be about information about errors and measures but also recall of products.
Manufacturers must report their corrective safety measures to their end customers and relevant authorities in the country where the products are sold and used.
Whose responsibility?
The safety message must clearly state the malfunctions of the product and the risks that may arise, as well as clearly state all the measures that users must follow.
It is the manufacturer who is responsible for the product itself being safe to use. The manufacturer guarantees that the product meets all requirements in the regulations by CE-marking the product.
The Swedish Medicines Agency checks that the manufacturer complies with the regulations through various market inspections.
Source: The Swedish Medicines Agency