Recall Issued for Several 3T Magnetom & Biograph MR Systems

A Class I recall has been issued by Siemens Healthineers for several of its 3T MR and PET/MR scanners because of a potentially serious safety issue with the magnet venting system.

There is 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.

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 so that the inspection can be carried out. Siemens is preparing to inspect devices and, if necessary, perform a correction to resolve the issue. Consignees were also instructed to ensure all users or customers are notified of the issue and to maintain the Customer Safety Advisory Notice is retained in product related records. Consignees were also requested to confirm receipt and acknowledgement of the notification.

For more details, visit accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=215855