Z-1663-2014Class II

MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD)...

Name: Z-1663-2014 MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD)...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-04-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-24 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and... on 2014-04-24. FDA classified it as Class II and gives the reason as "Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1663-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Posted: 2014-05-27
Terminated: 2015-01-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
Quantity in commerce: 5
Distribution: Distributed in the states of MN, CA, CO, TX, and IA.
Product codes and lots: model # 10432914 with serial numbers: 52126 52135 52108 52025 52101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1663-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1663-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-27

Product code LNH

K111242Class IIMagnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. / cleared 2011-11-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)