Reported Oct 8, 2025 · Ongoing
MAGNETOM Skyra fit. Model Number: 10849580.
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 Skyra fit
- Model Number10849580
- Lot codes and dates
- Model Number10849580
- UDI Numbers
(01)04056869006710(21)170068(01)04056869006710(21)170053(01)04056869006710(21)70022(01)04056869006710(21)170049(01)04056869006710(21)170018(01)04056869006680(21)162078(01)04056869006710(21)170109(01)04056869006710(21)170039(01)04056869006710(21)170066(01)04056869006710(21)170023(01)04056869006710(21)170030(01)04056869006710(21)170004(01)04056869006710(21)170016(01)04056869006710(21)170077(01)04056869006710(21)170058(01)04056869006710(21)170002(01)04056869006710(21)170050(01)04056869006710(21)170010(01)04056869006710(21)170019(01)04056869006710(21)70026(01)04056869006710(21)170056(01)04056869006710(21)170061(01)04056869006710(21)170105(01)04056869006710(21)170017(01)04056869006710(21)170041(01)04056869006710(21)70032(01)04056869006710(21)170111(01)04056869006710(21)170048(01)04056869006710(21)170101(01)04056869006710(21)170100(01)04056869006710(21)170060(01)04056869006710(21)170099(01)04056869006710(21)170036(01)04056869006710(21)170007(01)04056869006710(21)170001(01)04056869006710(21)170009(01)04056869006710(21)70020(01)04056869006710(21)170112(01)04056869006710(21)170113(01)04056869006710(21)170054(01)04056869006710(21)170047(01)04056869006710(21)170046(01)04056869006710(21)70023(01)04056869006710(21)70027(01)04056869006710(21)170110(01)04056869006710(21)170095(01)04056869006710(21)170075(01)04056869006710(21)170011(01)04056869006710(21)170081(01)04056869006710(21)170044(01)04056869006710(21)70028(01)04056869006710(21)170043(01)04056869006710(21)70031(01)04056869006710(21)70008
- Serial Numbers
170068170053700221700491700181701061701091700391700661700231700301700041700161700771700581700021700501700101700197002617005617006117010517001717004170032170111170048170101170100170060170099170036170007170001170009700201701121701131700541700471700467002370027170110170095170075170011170081170044700281700437003170008. Additional
- serial number added 2/25/2026170023. Additional
- serial Numbers Added 04/16/2026170013
- Amount recalled
- 56 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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