Recall Z-2662-2025 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
| Date | Sep 30, 2025 (initiated Aug 28, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare notified consignees on about 08/28/2025 via letter. Consignees were informed that Siemens Customer Service Organization will conduct an inspection of affected units to address the issue. If customers identify issues, they are cautioned to not reboot the system, to call their local Siemens Healthineers service organization, and grant access to the system. Siemens will inspect devices and perform a correction, if needed. Consignees were also instructed to ensure all users or customers are notified of the issue and to maintain the Customer Safety Advisory Notice. Consignees w |
| Quantity | 39 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyp |
| FDA record | Open on fda.gov |