—#101482

Product

MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101347
Affected lot / code info: Model numbers 10432914 and 10432915

Why it was recalled

Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.

Timeline

Recall initiated: 2011-06-20
Posted by FDA: 2011-08-10
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.