Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS2000 (Lot serial: >10 serial numbers.); Model Catalog: IS2000 (Lot serial: contact manufacturer.)
Model Catalog: IS3000 (Lot serial: all lots. contact mfg); Model Catalog: IS1200 (Lot serial: all lots. contact mfg); Model Catalog: IS2000 (Lot serial: all lots. contact mfg)
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.