Recall Z-2291-2014 ยท LZE Isometer
GE Healthcare, LLC
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
| Date | Aug 20, 2014 (initiated Jul 25, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated July 25, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions in the USA call 800-437-1171. For other countries contact your local GE Healthcare Representative. |
| Quantity | 334 (162 US, 172 OUS). |
| Distribution | USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) Ge Medical Systems, LLC, Nov 18, 2013 |