MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242,… Recall
Issued October 8, 2025 · Siemens Medical Solutions USA, Inc
In October 2025, Siemens Medical Solutions USA, Inc recalled the MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Medical Solutions USA, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Siemens Medical Solutions USA, Inc
- Category
- Health
- Recall date
- October 8, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan
- Recall number
- FDA-Z-2660-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Medical Solutions USA, Inc has 17 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.