Siemens Magnetom Skyra — Class II medical device recall Z-2464-2012
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-10-03, distributed nationwide. When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for
| Recall number | Z-2464-2012 |
|---|---|
| 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 | 2012-09-12 |
| Classified | 2012-09-26 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2014-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 370 |
| Model numbers | 10276755 |
Product
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Reason for recall
When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
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-2464-2012. 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.