Z-0940-2012

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

Name: Z-0940-2012 Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-01-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-01-26 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system on 2012-01-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0940-2012
Status: Terminated
Initiated: 2012-01-26
Posted: 2012-02-02
Terminated: 2014-01-31
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 128
Distribution: 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.
Product codes and lots: 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.

Product code LNH

K101347Class IIMagnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. / cleared 2010-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)