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Terminated

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.

FDA Recall Z-1663-2014 · Posted 2014-05-27

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-04-24
Date Terminated2015-01-08
Product Quantity5

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.

Firm Action

A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111242MAGNETOM AERA AND MAGNETOM SKYRASiemens Medical Solutions USA, Inc. · 2011-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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