Class II U.S. Food and Drug Administration

IMRIS Imaging Inc Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/ recall: Torque screw may crack or separate. If used

Recall published 9 months ago

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

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: Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

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-1034-2026
Published
January 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
IMRIS Imaging Inc
Product type
Medical devices
Units affected
122
Distribution
Nationwide
Made in
United States
Lot / code info
Affected UDI-DI: 00857534006011 00857534006592 00857534006608 00857534006615 Affected serial numbers: 10006206 10005998 10003999 10004026 10003796 10003811 10006629 10006630 10007514 10007515 10002486 10003048 10004215 10004216 10003794 10004231 10012064 10012310 10012311 10010990 10011142 10007914 10007971 10002391 10002969 10009132 10010058 10011570 10005134 10005711 10009569 10009878 10010057 10003903 10003906 10003546 10006187 10012838 10010639 10010666 10011925 10006692 10007246 10011463 10005092 10007237 10007509 10008416 10003407 10003793 10004195 10004975 10004993 10005136 10010381 10007906 10013179 10007510 10007511 10007245 10004449 10004961 10005849 10005851 10010747 10006730 10011187 10011307 10009593 10010003 10008073 10008354 10011546 10011571 10006207 10012127 10006631 10007777 10006411 10004466 10005445 10011645 10009015 10004291 10003985 10003987 10006204 10006205 10007235 10007236 10006412 10004775 10004323 10004942 10003936 10003937 10007130 10002695 10007126 10007128 10009228 10009210 10009583 10005480 10005481 10012839 10008645 10008670 10006693 10006694 10004317 10002403 10004673 10004671 10010572 10006212 10006203 10002968 10002715 10011186 10011265 10010059
UPC codes
00857534006011, 00857534006592, 00857534006608, 00857534006615

Products covered by this recall

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

Check your product

The notice names 9 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.

  • 00857534006011
  • 00857534006592
  • 00857534006608
  • 00857534006615

Model or item number

On the rating label, the box or the instruction sheet.

  • 119695-000
  • 119629-000
  • 119630-000
  • 113803-000
  • 113

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

IMRIS Imaging 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. 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.

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.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • 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.

Company contact: IMRIS 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 IMRIS Imaging Inc medical devices recalled?

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury. Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00857534006011, 00857534006592, 00857534006608; model number 119695-000, 119629-000, 119630-000. 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.

Where was the recalled product sold?

It was distributed nationwide.

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