GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)
This recall has been terminated (originally issued June 6, 2007).
- Recall Initiated
- January 24, 2007
- Posted
- June 6, 2007
- Terminated
- December 10, 2011
- Recall Number
- Z-0891-2007
- Quantity
- 5,190 Units
- Firm Location
- Milwaukee, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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 .
Distribution
Nationwide
Lot / Code Info
All serial numbers of Software Version 4.1
Root Cause
Other
Action Taken
GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software.