Recall Z-0170-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China
| Date | Nov 7, 2007 (initiated Dec 31, 2006) |
| Status | Terminated |
| Reason | Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury. |
| Root cause | Labeling design |
| Action | Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006 |
| Quantity | 163 |
| Distribution | Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MO, MS, MT, NJ, NY, OH, OK, PA, SD, VA, and WA, and countries of United Arab Emirats, Argentina, Belgium, Brazil China, Ivery Cost, Germany, Spain, France, United Kingdom, Hungary, Italy, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002611 | SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE Medical Systems, Oct 31, 2000 |