Recalls / —
—#127164
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.
- FDA product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K111242
- Affected lot / code info
- model # 10432914 with serial numbers: 52126 52135 52108 52025 52101
Why it was recalled
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Root cause (FDA determination)
Labeling design
Action the firm took
A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Distributed in the states of MN, CA, CO, TX, and IA.
Timeline
- Recall initiated
- 2014-04-24
- Posted by FDA
- 2014-05-27
- Terminated
- 2015-01-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.