Reported Oct 8, 2025 · Ongoing
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
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 BioMatrix
- Model Number11516217
- Lot codes and dates
- Model Number11516217
- UDI Numbers
(01)04056869299273(21)212087(01)04056869299273(21)212098(01)04056869299273(21)212088(01)04056869299273(21)212068(01)04056869299273(21)212081(01)04056869299273(21)212018(01)04056869299273(21)212041(01)04056869299273(21)212038(01)04056869299273(21)212047(01)04056869299273(21)212019(01)04056869299273(21)212037(01)04056869299273(21)212032(01)04056869299273(21)212049(01)04056869299273(21)212017(01)04056869299273(21)212064(01)04056869299273(21)212096(01)04056869299273(21)212065(01)04056869299273(21)212016(01)04056869299273(21)212023(01)04056869299273(21)212056(01)04056869299273(21)212054(01)04056869299273(21)212063(01)04056869299273(21)212051(01)04056869299273(21)212055(01)04056869299273(21)212021(01)04056869299273(21)212060(01)04056869299273(21)212011(01)04056869299273(21)212066(01)04056869299273(21)212074(01)04056869299273(21)212090(01)04056869299273(21)212034(01)04056869299273(21)212029(01)04056869299273(21)212097(01)04056869299273(21)212099(01)04056869299273(21)212039(01)04056869299273(21)212059(01)04056869299273(21)212030(01)04056869299273(21)212035(01)04056869299273(21)212036
- Serial Numbers
212087212098212088212068212081212018212041212038212047212019212037212032212049212017212064212096212065212016212023212056212054212063212051212055212021212060212011212066212074212090212034212029212097212099212039212059212030212035212036
- Amount recalled
- 39 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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