MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A — Class II medical device recall Z-1308-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-04-01, distributed nationwide. The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outpu
| Recall number | Z-1308-2015 |
|---|---|
| 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 | 2015-03-09 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 132 |
| Serial numbers | 41295, 41317, 41353, 41362, 41383, 41389, 41448, 41457, 41473, 41476, 41503, 41529, 41548, 41556, 41595, 41608, 41621, 41624, 41628, 41629, 41654, 41671, 41699, 41701, 41727 and 107 more |
| Model numbers | 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 |
Product
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
Reason for recall
The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
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-1308-2015. 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.