Recall Z-2464-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
| Date | Sep 26, 2012 (initiated Sep 12, 2012) |
| Status | Terminated |
| Reason | When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids). |
| Root cause | Device Design |
| Action | Siemens Healthcare sent a Customer Safety Advisory Notice dated September 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included updated instruction to all customers. For questions regarding this recall call 610-219-6300. |
| Quantity | 370 |
| Distribution | Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico. |
| FDA record | Open on fda.gov |