FDA Device recall Z-0467-2016
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD)
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of MAGNETOM systems, magnetic resonance diagnostic devices (MRDD) by Siemens Medical Solutions Usa, citing 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 instal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0467-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-07 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Reason
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.
Identifiers
| code_info | all units distributed since 1991 |
|---|
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-0467-2016%22
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