Recall Z-1600-2009 ยท DSI Detector And Alarm, Arrhythmia
GE Medical Systems Information Tecnology
GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.
| Date | Sep 4, 2009 (initiated Mar 10, 2009) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety. |
| Root cause | Component change control |
| Action | A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by GE Field Service team members. For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative. |
| Quantity | 352 |
| Distribution | Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH REPUBLIC, GERMANY, EGYPT, SPAIN, FRANCE, GREAT BRITAIN, ITALY, POLAND and SWEDEN. |
| 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 |