Reported Oct 8, 2025 · Ongoing
MAGNETOM Cima.X (DE). Model Number: 11647158.
Siemens Medical Solutions USA, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- MAGNETOM Cima.X (DE)
- Model Number11647158
- Lot codes and dates
- Model Number11647158
- 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
213029213006213062213043213041213034213035213028213031213018213061213005213021213022213056213030213039213025213063213057213026213020
- Amount recalled
- 22 units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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