Reported Oct 8, 2025 · Ongoing
Biograph mMR. Model Number: 10433372.
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?
- Biograph mMR
- Model Number10433372
- Lot codes and dates
- Model Number10433372
- UDI Number
(01)04056869006741(21)151032(01)04056869006741(21)151057(01)04056869006741(21)510535(01)04056869006741(21)151034(01)04056869006741(21)51003(01)04056869006741(21)151021(01)04056869006741(21)51055(01)04056869006741(21)151013(01)04056869006741(21)51064(01)04056869006741(21)151044(01)04056869006741(21)51038(01)04056869245188(21)51006(01)04056869006741(21)51030(01)04056869006741(21)151004(01)04056869006741(21)51022(01)04056869006741(21)151049(01)04056869006741(21)51007(01)04056869006741(21)151045(01)04056869006741(21)51032(01)04056869006741(21)51057(01)04056869006741(21)51015(01)04056869006741(21)151025(01)04056869006741(21)51048(01)04056869006741(21)51062(01)04056869006741(21)51010(01)04056869006741(21)51051
- Serial Numbers
15103215105751053151034510031510215105515101351064151044510385100651030151004510221510495100715104551032510575101515102551048510625101051051. Additional
- serial number added 01/23/202651007
- Amount recalled
- 27 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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