Reported Oct 8, 2025 · Ongoing
MAGNETOM Lumina (DE). Model Number: 11344916.
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 Lumina (DE)
- Model Number11344916
- Lot codes and dates
- Model Number11344916
- UDI Numbers
130 of 130 codes
(01)04056869230740(21)196458(01)04056869230740(21)196591(01)04056869230740(21)196655(01)04056869230740(21)196355(01)04056869230740(21)196733(01)04056869230740(21)196668(01)04056869230740(21)196477(01)04056869230740(21)196343(01)04056869230740(21)196553(01)04056869230740(21)196519(01)04056869230740(21)196366(01)04056869230740(21)196782(01)04056869230740(21)196617(01)04056869230740(21)196684(01)04056869230740(21)196502(01)04056869230740(21)196539(01)04056869230740(21)196280(01)04056869230740(21)196626(01)04056869230740(21)196511(01)04056869230740(21)196643(01)04056869230740(21)196796(01)04056869230740(21)196551(01)04056869230740(21)196495(01)04056869230740(21)196741(01)04056869230740(21)196621(01)04056869230740(21)196611(01)04056869230740(21)196544(01)04056869230740(21)196724(01)04056869230740(21)196776(01)04056869230740(21)196752(01)04056869230740(21)196372(01)04056869230740(21)196350(01)04056869230740(21)196841(01)04056869230740(21)196252(01)04056869230740(21)196508(01)04056869230740(21)196332(01)04056869230740(21)196496(01)04056869230740(21)196753(01)04056869230740(21)196375(01)04056869230740(21)196738(01)04056869230740(21)196260(01)04056869230740(21)196470(01)04056869230740(21)196765(01)04056869230740(21)196334(01)04056869230740(21)196288(01)04056869230740(21)196409(01)04056869230740(21)196737(01)04056869230740(21)196286(01)04056869230740(21)196604(01)04056869230740(21)196446(01)04056869230740(21)196362(01)04056869230740(21)196518(01)04056869230740(21)196619(01)04056869230740(21)196450(01)04056869230740(21)196678(01)04056869230740(21)196349(01)04056869230740(21)196261(01)04056869230740(21)196415(01)04056869230740(21)196386(01)04056869230740(21)196391
- Serial Numbers
130 of 130 codes
196458196591196655196355196733196668196477196343196553196519196366196782196617196684196502196539196280196626196511196643196796196551196495196741196621196611196544196724196776196752196372196350196841196252196508196332196496196753196375196738196260196470196765196334196288196409196737196286196604196446196362196518196619196450196678196349196261196415196386196391
- Amount recalled
- 130 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.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.