MAGNETOM Cima.X Upgrade (Siemens) – ice blockage potential (2025)
Severity assessment pending.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Products Sold
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Siemens Medical Solutions USA, Inc is recalling MAGNETOM Cima.X Upgrade. Model Number: 11689304. due to 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 contain. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026
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