Company:General Electric Medical Systems Information Technology
Date of Enforcement Report:6/20/2007
Class:ll
PRODUCT
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007
REASON
Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot.
CODE
All serial numbers of Software Version 4.1
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on March 13, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,190 units
DISTRIBUTION
Nationwide
