Company:GE Medical Systems Information Technologies, Inc.
Date of Enforcement Report 27/2018
Class lI:
PRODUCT
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information
Recall Number Z-0487-2018
REASON
CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Inc., Milwaukee, WI on 1/11/2018. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1803 units
DISTRIBUTION
Nationwide and Internationally
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