Company: GE Healthcare
Date of Enforcement Report:7/30/2014
Class lI:
PRODUCT
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Recall Number Z-2085-2014
REASON
GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI on 6/132014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
41,992 (20,509 US; 21,483 OUS)
DISTRIBUTION
Nationwide and Internationally
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