MAGNETOM Cima.X Upgrade recall
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Why was MAGNETOM Cima.X Upgrade 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4 system (1 US; 3 OUS)
- Distribution
- US distribution to California. International distribution to Australia, Germany, Great Britian.
- Recall date
- November 19, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)