Recall Z-1232-2009 ยท DSI Detector And Alarm, Arrhythmia
GE Medical Systems Information Tecnology
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Centr
| Date | May 4, 2009 (initiated Feb 27, 2009) |
| Status | Terminated |
| Reason | GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction. |
| Root cause | Software design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated February 27, 2009. The letter was addressed to the Chief of Nursing/Chief of Biomedical Engineering and Risk Manager/Healthcare Administrator. The letter describes the Safety Issue, Affected Product Details, Safety instructions, Product Correction, and Contact Information. Direct questions to your local GE Healthcare Field Service Representative or the GE Healthcare Technologies Support Center by calling 1-800-558-7044 (Option 2, Technical Support). |
| Quantity | 12,737 |
| Distribution | Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY, WI, and WV) and countries of UNITED ARAB EMIRATES, AUSTRIA, A |
| 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 |
| K053356 | MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies, Apr 19, 2006 |
| K062976 | MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER Ge Medical Systems Information Technologies, Mar 16, 2007 |