Catalog Number: N5426860 & N5426960 Model Number: OTV-S200 & OTV-S300 Serial Number: OTV-S200: Serialnumbers lower than 771... are affected by this FSCA OTV-S300: Serialnumbers lower than 771... are affected by this FSCA
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.