Class 1 Device Recall MAGNETOM Cima.X Upgrade

• Date Initiated by Firm: October 01, 2025
• Date Posted: November 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0431-2026
• Recall Event ID: 97845
• 510(K)Number: K231587
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: MAGNETOM Cima.X Upgrade. Model Number: 11689304.
• Code Information: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Rebecca Tudor; 484-323-4198
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 4 system (1 US; 3 OUS)
• Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH