Class II U.S. Food and Drug Administration

FUJIFILM Healthcare Americas Corporation FDR Visionary Suite recall: It was found that the contacts of the electromagnetic contactors used inside

Recall published 9 months ago

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

The hazard: Fire or burn hazard

A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

What the notice says: It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

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-1299-2026
Published
February 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
FUJIFILM Healthcare Americas Corporation
Product type
Medical devices
Units affected
16 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: CH-200; (1) Version: 566-16130-23; UDI-DI: 04540217052226; Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001; (2) Version: 566-16130-31; UDI-DI: 04540217057436; Serial numbers: MP95AA783001; (3) Version: 566-16130-33; UDI-DI: 04540217057450; Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;
UPC codes
04540217052226, 04540217057436, 04540217057450

Products covered by this recall

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Check your product

The notice names 11 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.

  • 04540217052226
  • 04540217057436
  • 04540217057450

Model or item number

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

  • CH-200

Serial number

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

  • MP95A9F6A001
  • MP95A9F6B001
  • MP95A9F74001
  • MP95AA783001
  • MP95AA983001
  • MP95AA983002
  • MP95AA983003

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 Fire

FUJIFILM Healthcare Americas Corporation — A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  3. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  4. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.

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: FUJIFILM Healthcare Americas Corporation — 81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160

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 FUJIFILM Healthcare Americas Corporation medical devices recalled?

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04540217052226, 04540217057436, 04540217057450; model number CH-200. 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?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

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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