Class I U.S. Food and Drug Administration

IMPRIS Imaging Inc IMRIS Operating Suite, Neuro III-SV iMRI System recall: There is a potential safety issue associated with the magnet venting paths

Recall published 12 months ago

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The hazard: High-powered magnet hazard

Loose high-powered magnets are the hazard here. The danger comes from swallowing more than one, because they then find each other through the gut wall.

What the notice says: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which 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-0161-2026
Published
November 5, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
IMPRIS Imaging Inc
Product type
Medical devices
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
IMRIS Part Number(s): 105118-000, UDI/DI None predates UDI; 105118-001, UDI/DI None predates UDI; 105117-003, UDI/DI None predates UDI; 105117-004, UDI/DI None predates UDI; 105048-000, UDI/DI None predates UDI; 105048-001, UDI/DI None predates UDI; 105103-001, UDI/DI None predates UDI; 105071-004, UDI/DI None predates UDI; 105824-000, UDI/DI 00857534006189; 105828-000, UDI/DI 00857534006165; 116189-000, UDI/DI 00857534006202; 118396-000, UDI/DI 00857534006196.
UPC codes
00857534006189, 00857534006165, 00857534006202

Products covered by this recall

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

Check your product

The notice names 3 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.

  • 00857534006189
  • 00857534006165
  • 00857534006202

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

IMPRIS Imaging Inc — Loose high-powered magnets are the hazard here. The danger comes from swallowing more than one, because they then find each other through the gut wall.

  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.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.

Company contact: IMPRIS Imaging Inc — 1230 Chaska Creek Way Ste 100, Chaska, MN, 55318-2707

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 IMPRIS Imaging Inc medical devices recalled?

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. There is a potential safety issue associated with the magnet venting paths of…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00857534006189, 00857534006165, 00857534006202. 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?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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