Use cautionMedical device recall · FDA · Published September 15, 2025
FUJIFILM FDR Visionary Suite CH-200 X-ray Tube Shaft Break Risk
FUJIFILM Healthcare recalls CH-200 X-ray units with specific model numbers due to risk of X-ray tube shaft breaking during operation, potentially causing injury. Affected units include model versions 566-16130-23, 566-16130-31, and 566-16130-33.
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
FUJIFILM Healthcare is recalling CH-200 X-ray units with model numbers 566-16130-23, 566-16130-31, and 566-16130-33 because the X-ray tube mounting shaft may break during use. This could lead to the protective parts failing, increasing the risk of injury if the unit is operated incorrectly. Read more at govinfonow.com/recall/51293-fujifilm-fdr-visionary-suite-ch-200-x-ray-tube-shaft.
“FUJIFILM FDR Visionary Suite CH-200 X-ray Tube Shaft Break Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51293-fujifilm-fdr-visionary-suite-ch-200-x-ray-tube-shaft. Based on FDA recall #Z-0044-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2026%22&limit=1).
The FDA announced on Sept. 15, 2025, that FUJIFILM Healthcare Americas Corporation is recalling FDR Visionary Suite CH-200 X-ray devices due to a potential shaft breakage hazard. The recall affects 16 units distributed in Alaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio, and Wisconsin.
The FDA stated that the shaft for mounting the X-ray tube unit on the support may break. Additionally, protective parts might not work effectively if the shaft breaks while the device is operated toward the front while lifting.
Context
GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has had 13 other recalls since Oct. 14, 2021. Recent similar recalls include a July 22, 2026, recall of FUJIFILM Synapse PACS Software v7.4.310 for inaccurate ruler measurements and a Jan. 9, 2026, recall of the same FDR Visionary Suite CH-200 model for overheating risks. Other recent recalls of similar products include a Oct. 16, 2025, Shimadzu Ceiling X-Ray Tube Support recall for potential shaft breakage and an Aug. 4, 2026, Canon Alphenix X-ray Systems recall for loose fixing screws.
How to tell if you have this one
Check for model numbers 566-16130-23, 566-16130-31, or 566-16130-33 on the unit. Serial numbers starting with MP95A8F5A001 through MP95AA988002 also indicate affected units.
Brand
FUJIFILM Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Numbers
Identify if your unit has model numbers 566-16130-23, 566-16130-31, or 566-16130-33.
Contact Manufacturer
Reach out to FUJIFILM Healthcare for guidance on next steps if your unit is affected.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: AK, CA, FL, IL, MA, NH, OH, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, California, Florida, Illinois, Massachusetts, New Hampshire, Ohio, Wisconsin.
Recall timeline
FDA published this recall 30 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-0044-2026 (September 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0044-2026 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.