Company: GE Healthcare Finland Oy
Date of Enforcement Report 10/17/2018
Class II:
PRODUCT
GE Healthcare CARESCAPE Monitor B450
Recall Number: Z-0095-2019
REASON
When multiple CARESCAPEMonitor B450 or B850 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 9/4/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
Worldwide Distribution-US Nationwide