Recall Z-0519-2008 ยท DSI Detector And Alarm, Arrhythmia
General Electric Medical Systems Information Technology
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
| Date | Jan 17, 2008 (initiated Nov 8, 2007) |
| Status | Terminated |
| Reason | Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors. |
| Root cause | Software design |
| Action | A "GE Urgent Medical Device Correction" letter was sent to consignees on 10/16/2007. The letter described the problem and product involved. The letter also gave short term recommendations. A long term solution is being worked on by GE and will be announced when determined. |
| Quantity | 3, 116 |
| Distribution | Worldwide-USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, and District of Columbia and countries of The United Kingdom, Turkey, Thailand, Tsiwan, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062976 | MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER Ge Medical Systems Information Technologies, Mar 16, 2007 |