—#216712

Product

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K231587
Affected lot / code info: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

Why it was recalled

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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 (FDA determination)

Under Investigation by firm

Action the firm took

Siemens Healthcare notified consignees on about 10/01/2025 via "URGENT: MEDICAL DEVICE CORRECTION" letter dated 08/27/2025. 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 for the inspection. 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, to maintain the Customer Safety Advisory Notice is retained in product related records, to confirm receipt and acknowledgement of the notification, and if the affected system is no longer in the consignee's possession, notify the new owner. A follow up communication was sent to consignees on about 10/13/2025 via letter. This informed users of further details and additional necessary safety actions. If a specific "Magnent Supervision" error message appears on the host computer, no further scans can be performed, and you are requested to: not reboot the system, remove the patient from the system, lock/secure all access to the scanning room with the system remaining energized at field, post a DO NOT USE notice on or near the device, and call the Siemens Healthineers service organization. In addition, Siemens reminded users that the Magnet Stop button is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency. Ensure all designated emergency exit routes remain unobstructed and are marked. Our service organization will contact you shortly to arrange a date to perform the corrective action. If you have any questions, please feel free to contact our service organization at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US distribution to California. International distribution to Australia, Germany, Great Britian.

Timeline

Recall initiated: 2025-10-01
Posted by FDA: 2025-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.