FDA Device recall Z-2656-2025
MAGNETOM Cima.X (DE). Model Number: 11647158
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Cima.X (DE). Model Number: 11647158 by Siemens Medical Solutions Usa, citing there is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the desi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2656-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
MAGNETOM Cima.X (DE). Model Number: 11647158.
Reason
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Identifiers
| code_info | Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)…Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)213062, (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213035, (01)04056869975221(21)213028, (01)04056869975221(21)213031, (01)04056869975221(21)213018, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213021, (01)04056869975221(21)213022, (01)04056869975221(21)213056, (01)04056869975221(21)213030, (01)04056869975221(21)213039, (01)04056869975221(21)213025, (01)04056869975221(21)213063, (01)04056869975221(21)213057, (01)04056869975221(21)213026, (01)04056869975221(21)213020. Serial Numbers: 213029, 213006, 213062, 213043, 213041, 213034, 213035, 213028, 213031, 213018, 213061, 213005, 213021, 213022, 213056, 213030, 213039, 213025, 213063, 213057, 213026, 213020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2656-2025%22
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