Recall Z-0891-2007 ยท DSI Detector And Alarm, Arrhythmia
General Electric Medical Systems Information Technology
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)
| Date | Jun 6, 2007 (initiated Jan 24, 2007) |
| Status | Terminated |
| 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 . |
| Root cause | Other |
| Action | 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. |
| Quantity | 5,190 Units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032370 | CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies, Aug 13, 2003 |