FDA Device recall Z-1663-2014
MAGNETOM Aera magnetic resonance system
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of MAGNETOM Aera magnetic resonance system by Siemens Medical Solutions Usa, citing siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1663-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-24 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | CA, CO, IA, MN, TX |
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.
Identifiers
| code_info | model # 10432914 with serial numbers: 52126 52135 52108 52025 52101 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1663-2014%22
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