Class I U.S. Food and Drug Administration

Siemens Medical Solutions USA, Inc Biograph One recall: There is a potential for an ice blockage to form or currently exist within

Recall published 1+ years ago

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, 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

This recall concerns small, strong magnets that can detach. Teenagers are at risk as well as toddlers, because magnets get used to mimic tongue and lip piercings.

What the notice says: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, 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-2655-2025
Published
October 8, 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
1 unit
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: 11689172. UDI Numbers: (01)4068151020472(21)238008. Serial Number: 238008.
UPC codes
4068151020472

Products covered by this recall

BIOGRAPH One (DE). Model Number: 11689172.

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.

  • 4068151020472

Serial number

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

  • 238008. — 1 unit

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 — This recall concerns small, strong magnets that can detach. Teenagers are at risk as well as toddlers, because magnets get used to mimic tongue and lip piercings.

  1. Put the product out of reach and count the magnets against the number the instructions say it should have.
  2. If any are unaccounted for and a child could have reached them, go to an emergency department and tell them magnets may have been swallowed.
  3. Make sure older children know that using magnets as fake piercings is a recognised route to a serious injury.
  4. Follow the remedy described on this page rather than keeping the item with the magnets glued back in.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

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 magnet venting system. In the event of a quench, 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 magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 4068151020472. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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