Company: General Electric Medical Systems Information Technology
Date of Enforcement Report 2/13/2008
Class:ll
PRODUCT
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). (System hardware consists of a processing unit and a monitor), Recall # Z-0280-2008
REASON
Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.
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
6,217 units
DISTRIBUTION
Nationwide and Internationally
