—#112954

Product

Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072237, K101347, K103429, K121160
Affected lot / code info: Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-09-12
Posted by FDA: 2012-09-26
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.