Recall Z-0121-2013 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can als
| Date | Oct 23, 2012 (initiated Oct 12, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and |
| Root cause | Software design |
| Action | GE Healthcare, LLC sent an " Urgent Medical Device Correction" letter dated October 12, 2012 to all affected customers. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Mangers, and Mangers of Radiology / Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details and Product Correction. For questions or concerns contact your local GE Healthcare Service Representative. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890. |
| Quantity | 210 |
| Distribution | Worldwide distribution: USA (Nationwide) in the states of: AL, CA, FL, GA, IL, IN, KS, LA, MD, MA, MN, MS, MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV. AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL,ITALY, |
| FDA record | Open on fda.gov |