Recall Z-0280-2008 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. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor)
| Date | Feb 1, 2008 (initiated Jan 24, 2007) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07. As a Short Term Solution, GE recommends that user reboot of system according to instructions and precautions in Service Manual at least once every three months. Also, take the necessary precautions to ensure that system is shut down properly. This will decrease the likelihood of a continuous reboot. If system continues to reboot, GE suggest that user contact Technical Support at 1-800-588-7044 (Press Option 2) and ask for Technical Support. As for a Long Term Solution, GE will provide |
| Quantity | 6,217 Units (1,549 OUS, 4,668 within US) |
| Distribution | Worldwide Distribution - USA (excluding DE, HI, ID, MT, ND, SD, VT), Peurto Rico, Washington DC and including the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungaria, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Mal |
| 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 |