RecallRadar

FDA Device recall Z-1663-2014

MAGNETOM Aera magnetic resonance system

On 2014-06-04 the FDA classified a Class II recall of MAGNETOM Aera magnetic resonance system by Siemens Medical Solutions Usa, citing siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1663-2014
ClassificationClass II
Statusterminated
Initiated2014-04-24
Published2014-06-04
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionCA, CO, IA, MN, TX

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1663-2014%22

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