FDA Device recall Z-0617-2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon…
- FDA Device
- Class II
- ongoing
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon… by Ge Healthcare, citing the magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0617-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-23 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
Reason
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Identifiers
| code_info | All systems. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0617-2022%22
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