Device 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.
Z-1663-2014
Product summary
- Event
- Event 68221
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1663-2014
Official wording
Reason: Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Code information: model # 10432914 with serial numbers: 52126 52135 52108 52025 52101
Distribution pattern: Distributed in the states of MN, CA, CO, TX, and IA.
Derived failure modes
-
Unknown
Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.