FDA recall, , Moderate risk
FUJIFILM FDR Visionary Suite
The FDR Visionary Suite X-ray high-voltage generator can overheat and damage parts, possibly causing smoke.
Summary by Recall Canary from the FDA notice
What happened
FUJIFILM Healthcare Americas Corporation of Lexington, Massachusetts, voluntarily recalled the FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3).
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 may damage the surrounding parts. It may also cause smoke.
The company began the recall on January 9, 2026. The FDA added it to the Enforcement Report on February 5, 2026, and classified it on February 5, 2026. Distribution was in the states of AK, CA, CT, FL, IL, NH, OH, WI. Customers were told by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
CH-200
- UDI-DI
- 04540217052226
- 04540217057436
- 04540217057450
From the FDA notice
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Feb 2, 2026
- Sold in
US Nationwide distribution in the states of Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio, Wisconsin.
- Recalled by
- FUJIFILM Healthcare Americas CorporationLexington, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98124
- Recall number
- Z-1299-2026
- Quantity recalled
- 16 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from FUJIFILM Healthcare Americas Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
FUJIFILM Healthcare Americas Corporation began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
