Recall – Patient Monitor

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

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