Class I U.S. Food and Drug Administration

Siemens Medical Solutions USA, Inc Magnetom Cima.X Upgrade recall: There is a potential for an ice blockage to form or currently exist within

Recall published 11 months ago

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.

The hazard: High-powered magnet hazard

The problem with this product is magnets coming loose. A magnet ingestion looks like an ordinary stomach upset for the first day or two, which is exactly why these recalls are issued.

What the notice says: 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.

Why it matters: Loose high-powered magnets are dangerous when more than one is swallowed. They attract each other through the walls of the intestine and pinch the tissue trapped between them, an injury that usually needs surgery.

Symptoms and when to call a doctor

If you think a child has swallowed magnets — even if they seem entirely well — go to an emergency department and say magnets are involved. Early symptoms are indistinguishable from a stomach bug: stomach pain, vomiting, poor appetite. A single magnet may pass on its own; two or more rarely do, and the team needs to know how many are unaccounted for.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0431-2026
Published
November 19, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Siemens Medical Solutions USA, Inc
Product type
Medical devices
Units affected
4 system (1 US; 3 OUS)
Distribution
California
Made in
United States
Lot / code info
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
UPC codes
04056869975245

Products covered by this recall

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04056869975245

Serial number

On the rating plate, often next to the date of manufacture.

  • 237304. — 4 system

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Magnets

Siemens Medical Solutions USA, Inc — The problem with this product is magnets coming loose. A magnet ingestion looks like an ordinary stomach upset for the first day or two, which is exactly why these recalls are issued.

  1. Put the product out of reach and count the magnets against the number the instructions say it should have.
  2. Make sure older children know that using magnets as fake piercings is a recognised route to a serious injury.
  3. Follow the remedy described on this page rather than keeping the item with the magnets glued back in.
  4. Check under furniture and along skirting boards — stray magnets travel further than you would expect.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Siemens Medical Solutions USA, Inc — 40 Liberty Blvd, Malvern, PA, 19355-1418

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Siemens Medical Solutions USA, Inc medical devices 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. There is a potential for an ice blockage to form or currently exist within the…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04056869975245. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Put the product out of reach and count the magnets against the number the instructions say it should have.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Which states were affected?

The notice lists California.

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