Reported Oct 8, 2025 · Ongoing
MAGNETOM Prisma. Model Number: 10849582.
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 Prisma
- Model Number10849582
- Lot codes and dates
- Model Number10849582
- UDI Numbers
101 of 101 codes
(01)04056869006727(21)166324(01)04056869006727(21)66104(01)04056869006727(21)166097(01)04056869006727(21)166024(01)04056869006727(21)166018(01)04056869006727(21)66109(01)04056869006727(21)66111(01)04056869006727(21)166114(01)04056869006727(21)166242(01)04056869006727(21)166268(01)04056869006727(21)166200(01)04056869006727(21)166047(01)04056869006727(21)66047(01)04056869006727(21)166292(01)04056869006727(21)166041(01)04056869006727(21)166007(01)04056869006727(21)166037(01)04056869006727(21)66112(01)04056869006727(21)166025(01)04056869006727(21)166003(01)04056869006727(21)66102(01)04056869006727(21)166254(01)04056869006727(21)166074(01)04056869006727(21)166281(01)04056869006727(21)166220(01)04056869006727(21)66027(01)04056869006727(21)166221(01)04056869006727(21)166321(01)04056869006727(21)166193(01)04056869006727(21)166012(01)04056869006727(21)166121(01)04056869006727(21)66053(01)04056869006727(21)166160(01)04056869006727(21)66094(01)04056869006727(21)166310(01)04056869006727(21)66028(01)04056869006727(21)166102(01)04056869006727(21)166034(01)04056869006727(21)166030(01)04056869006727(21)66106(01)04056869006727(21)166235(01)04056869006727(21)166273(01)04056869006727(21)166201(01)04056869006727(21)166345(01)04056869006727(21)166225(01)04056869006727(21)66044(01)04056869006727(21)66018(01)04056869006727(21)166006(01)04056869006727(21)166009(01)04056869006727(21)166295(01)04056869006727(21)166227(01)04056869006727(21)166188(01)04056869006727(21)166046(01)04056869006727(21)166296(01)04056869006727(21)166298(01)04056869006727(21)66022(01)04056869006727(21)66057(01)04056869006727(21)166326(01)04056869006727(21)166327(01)04056869006727(21)166048
- Serial Numbers
101 of 101 codes
166324661041660971660241660186610966111166114166242166268166200166047660471662921660411660071660376611216602516600366102166254166074166281166220660271662211663211661931660121661216605316616066094166310660281661021660341660306610616623516627316620116634516622566044660181660061660091662951662271661881660461662961662986602266057166326166327166048
- Amount recalled
- 101 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.