MAGNETOM Cima.X recallZ-0431-2026 · Siemens Medical Solutions USA, Inc · initiated Oct 1, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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. ***Update 04/22/2026*** On April 15, 2026 URGENT: MEDICAL DEVICE CORRECTION update letters were sent
Recall details
- Recall number
- Z-0431-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 1, 2025
- Posted by the FDA
- Nov 12, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4 system (1 US; 3 OUS)
- Product code
- LNH
- FDA submissions
- K231587
- Distribution
- US distribution to California. International distribution to Australia, Germany, Great Britian.
Product description
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Code information (models, lots, serial numbers)
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAGNETOM Cima.X 11689304Siemens Healthcare GmbH · System, nuclear magnetic resonance spectroscopic2 recalls0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K231587 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MAGNETOM Cima.X 11647158Siemens Healthcare GmbH · System, nuclear magnetic resonance spectroscopic2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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