—#107139

Product

Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101347
Affected lot / code info: Serial numbers 45115, 41187, 41157, 41116, 45072, 45081, 41089, 41215, 41144, 41201, 45148, 41164, 41088, 41245, 41168, 41152, 45140, 45152, 45143, 45195, 41222, 41150, 45129, 45118, 45119, 41134, 41138, 45182, 45213, 41167, 41100, 52024, 45196, 45197, 41180, 41130, 45088, 41189, 41104, 41246, 41176, 45138, 15084, 41071, 45120, 45107, 41271, 45135, 45141, 41264, 45110, 41279, 41231, 41284, 41235, 45221, 45223, 41276, 41278, 41137, 41225, 41131, 41141, 41233, 45185, 41236, 41238, 45149, 41191, 45074, 45106, 45006, 45201, 41133, 41265, 41188, 45220, 41140, 41079, 45160, 45167, 41194, 45155, 45130, 41241, 41170, 45147, 41006, 45219, 45085, 45150, 45031, 41162, 45121, 45134, 45099, 45038, 45079, 41109, 41156, 45116, 41249, 45128, 45078, 45214, 41103, 45229, 41234, 45181, 52025, 52021, 45105, 45132, 41149, 45228, 45060, 45080, 45208, 41083, 45230, 45205, 41097, 41181, 45093, 45199, 45184, 45071, and 45111.

Why it was recalled

During product monitoring firm has discovered 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 existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens Medical Solutions sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated November 24, 2010 to all affected customers. The letter described the product, problem, and actions to be taken. Contact the firm at 610-219-4834 for questions regarding this recall.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-including the states of AK, AZ, CA, CT, DE, FL, GA, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.

Timeline

Recall initiated: 2012-01-26
Posted by FDA: 2012-02-02
Terminated: 2014-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107139. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.