Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
Mammomat Inspiration System with software version VB30 and Biopsy functionalityCatalogue Number: 10140000 (with software version VB30 and with a Biopsy option)ARTG Number: 274541