Reported Oct 8, 2025 · Ongoing
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977,…
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 (DE)
- Model Number10432915. 510(k)
- Numbers
K101347K111242K123510K133435K140253K141977K142515K153343K173592K202014K231560
- Lot codes and dates
- Model Number10432915
- UDI Numbers
578 of 578 codes
(01)04056869006703(21)45046(01)04056869006703(21)45115(01)04056869006703(21)45398(01)04056869006703(21)145760(01)04056869006703(21)145811(01)04056869006703(21)45549(01)04056869006703(21)45834(01)04056869006703(21)146099(01)04056869006703(21)146110(01)04056869006703(21)45047(01)04056869006703(21)146093(01)04056869006703(21)46066(01)04056869006703(21)45788(01)04056869006703(21)146082(01)04056869006703(21)45124(01)04056869006703(21)45185(01)04056869006703(21)45332(01)04056869006703(21)45466(01)04056869006703(21)145390(01)04056869006703(21)45732(01)04056869006703(21)45918(01)04056869006703(21)45380(01)04056869006703(21)46182(01)04056869006703(21)45735(01)04056869006703(21)45233(01)04056869006680(21)162026(01)04056869006703(21)145008(01)04056869006703(21)145473(01)04056869006703(21)145095(01)04056869006703(21)145664(01)04056869006703(21)45200(01)04056869006703(21)146098(01)04056869006703(21)146086(01)04056869006703(21)45805(01)04056869006703(21)45812(01)04056869006703(21)45397(01)04056869006703(21)46264(01)04056869006703(21)45499(01)04056869006703(21)45749(01)04056869006703(21)45289(01)04056869006703(21)46220(01)04056869006703(21)45369(01)04056869006703(21)45267(01)04056869006703(21)45253(01)04056869006703(21)45060(01)04056869006703(21)146103(01)04056869006703(21)45333(01)04056869006703(21)146123(01)04056869006703(21)46147(01)04056869006703(21)145721(01)04056869006703(21)145840(01)04056869006703(21)145088(01)04056869006703(21)146124(01)04056869006703(21)45841(01)04056869006703(21)45890(01)04056869006703(21)46295(01)04056869006703(21)45306(01)04056869006703(21)45519(01)04056869006703(21)145905(01)04056869006703(21)46242
- Serial Numbers
569 of 569 codes
450464511545398145760145811455494583414609914611045047146093460664578814608245124451854533245466145390457324591845380461824573545233145735145008145473145095145664452001460981460864580545812453974626445499457494528946220453694526745253450601461034533314612346147145721145840145088146124458414589046295453064551914590546242
- serial numbers added 11/14/2025
453954544245291. Additional
- serial numbers added 01/23/2026
4510845129. Additional
- serial numbers added 2/25/2026
4563546150145696462204542545733451864626845913
- Amount recalled
- 586 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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