MAGNETOM systems — Class II medical device recall Z-0467-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-12-30, distributed nationwide. Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rar
| Recall number | Z-0467-2016 |
|---|---|
| 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 | 2015-12-07 |
| Classified | 2015-12-22 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM |
| Quantity | 3,752 units |
Product
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Reason for recall
Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.
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-0467-2016. 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.