MAGNETOM Aera magnetic resonance system — Class II medical device recall Z-1663-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-06-04, distributed in CA, CO, IA, MN, TX. Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted i
| Recall number | Z-1663-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2014-04-24 |
| Classified | 2014-05-27 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2015-01-08 |
| Distributed | CA, CO, IA, MN, TX |
| Quantity | 5 |
| Serial numbers | 52025, 52101, 52108, 52126, 52135 |
| Model numbers | 10432914 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1663-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.