Recall Z-0426-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.
| Date | Nov 19, 2010 (initiated Aug 23, 2010) |
| Status | Terminated |
| Reason | If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose. |
| Quantity | 202 |
| Distribution | Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, S |
| FDA record | Open on fda.gov |