Use cautionMedical device recall · FDA · Published January 9, 2026
FUJIFILM FDR Visionary Suite CH-200 X-ray Device Recall: Risk of Overheating and Smoke
FUJIFILM Healthcare recalls specific models of X-ray high-voltage generators (CH-200) due to risk of overheating and smoke after power cut. Affected units have unique serial numbers and versions.
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.
FUJIFILM Healthcare is recalling certain X-ray high-voltage generators (FDR Visionary Suite CH-200) because internal electrical contacts can weld, causing overheating and potential smoke even after power is turned off. This poses a fire risk if the device is used improperly. Read more at govinfonow.com/recall/50176-fujifilm-fdr-visionary-suite-ch-200-x-ray-device-recall.
“FUJIFILM FDR Visionary Suite CH-200 X-ray Device Recall: Risk of Overheating and Smoke.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50176-fujifilm-fdr-visionary-suite-ch-200-x-ray-device-recall. Based on FDA recall #Z-1299-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2026%22&limit=1).
The FDA announced on Jan. 9, 2026, that FUJIFILM Healthcare Americas Corporation is voluntarily recalling the FDR Visionary Suite X-ray high-voltage generator due to a hazard of overheating and potential smoke. The agency issued recall number Z-1299-2026 for the Class II device.
How to tell if you have it
Brand: FUJIFILM Healthcare
Product: FDR Visionary Suite
Model Number: CH-200
Version: 566-16130-23, 566-16130-31, or 566-16130-33
Quantity: 16 units
The hazard
The contacts of the electromagnetic contactors inside the cabinet were found to be welded, which may allow current to continue supplying to the power supply circuit even when the device is turned off. This condition can cause the circuit to overheat and damage surrounding parts, and it may also cause smoke.
Context
GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has 13 other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include OXOS MC2 Portable X-Ray System: Defective Circuit Board Overheats (June 11, 2026) and BD Pyxis MedStation ES Tower 352 Medication Cabinet Recall: Fingerprint Scanner Overheats Risk (April 30, 2026).
How to tell if you have this one
Check for the model number CH-200 and specific versions: 566-16130-23, 566-16130-31, or 566-16130-33. Affected units have unique serial numbers listed in the recall notice.
Brand
FUJIFILM Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the model number (CH-200) and version numbers (566-16130-23, 566-16130-31, or 566-16130-33) on your X-ray generator.
Stop Using Immediately
If your device matches the recalled model and version, stop using it immediately to prevent overheating or smoke.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1299-2026 (January 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1299-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.