Recall – CARESCAPE Monitor

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

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