CLASS II Device recall · Reported 4 Jun 2014 · FDA Enforcement Report

Magnetom Aera magnetic resonance system recalled

Siemens Medical Solutions USA is recalling Magnetom Aera magnetic resonance system, distributed in California, Colorado, Iowa, Minnesota, Texas. The recall was initiated on 24 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmodel # 10432914 with serial numbers: 52126 52135 52108 52025 52101

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1663-2014
FDA event ID: 68221
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2014
FDA classified: 27 May 2014
Reported: 4 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

24 Apr 2014	Recall initiated by company
27 May 2014	Classified by FDA	+33 days
4 Jun 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed in the states of MN, CA, CO, TX, and IA.

California Colorado Iowa Minnesota Texas

Questions about this recall

Why was it recalled?

Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.

Which lots are affected?

model # 10432914 with serial numbers: 52126 52135 52108 52025 52101

Where was it sold?

Distributed in the states of MN, CA, CO, TX, and IA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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