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.
The FSCA affects all models and all serial numbers of the below-mentioned HCU 40 device below S/N 90441598 :
• 70104.4054 HCU 40 High Voltage
• 70105.4917 HCU 40 Low Voltage