FDA-Device2014-06-04Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Sold states
Distributed in the states of MN, CA, CO, TX, and IA.
Affected count
5
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1663-2014Don't want to check this manually?
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