Recall Z-1663-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1663-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-24

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-04-24, terminated 2015-01-08. It names one FDA 510(k) clearance: K111242. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Terminated: 2015-01-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K111242 — MAGNETOM AERA AND MAGNETOM SKYRASiemens Medical Solutions USA, Inc.·cleared 2011-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.