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.
Reported: June 4, 2014 Initiated: April 24, 2014 #Z-1663-2014
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 5
- Distribution
- Distributed in the states of MN, CA, CO, TX, and IA.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1663-2014.
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