Company: GE Healthcare Finland Oy
Date of Enforcement Report 7/11/2018
Class II:
PRODUCT
GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018
REASON
When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
RECALLING FIRM/MANUFACTURER
GE Healthcare Finland Oy, Helsinki, Finland on 5/25/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
69231 units
DISTRIBUTION
Worldwide