Z-2979-2011

MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

Name: Z-2979-2011 MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-06-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-06-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging on 2011-06-20. The reason FDA records is "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...". 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-2979-2011
Status: Terminated
Initiated: 2011-06-20
Posted: 2011-08-10
Terminated: 2014-01-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 26
Distribution: 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.
Product codes and lots: Model numbers 10432914 and 10432915

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)