Fujifilm FDR Visionary Suite CH-200 X-ray Tube Risk: Cracks May Cause Injury
Fujifilm recalls FDR Visionary Suite X-ray systems with CH-200 model due to potential cracks in the tube holding shaft that could lead to injury. Affected units have specific serial numbers and UDI codes.
Use caution until it’s fixed
A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Contact the company
What happened, in plain English
Fujifilm is recalling X-ray systems with the CH-200 model because cracks in the tube holding shaft near the base of the mounting flange could cause injury. This affects specific units with serial numbers MP95A9F6B001, MP95A9F6A001, and MP95A8F5A001. Read more at govinfonow.com/recall/73853-fujifilm-fdr-visionary-suite-ch-200-x-ray-tube-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73853-fujifilm-fdr-visionary-suite-ch-200-x-ray-tube-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0232-2018
Cite this page
“Fujifilm FDR Visionary Suite CH-200 X-ray Tube Risk: Cracks May Cause Injury.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73853-fujifilm-fdr-visionary-suite-ch-200-x-ray-tube-risk. Based on FDA recall #Z-0232-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2018%22&limit=1).
Why it’s dangerous
Cracks in the tube holding shaft near the base of the mounting flange could lead to the X-ray tube assembly becoming unstable. This might cause injury to users or patients during operation if the crack worsens over time.
Who’s affected
Medical facilities using the FDR Visionary Suite X-ray systems with CH-200 model are most at risk. Patients and staff could be affected if the device is used without addressing the crack issue.
How to tell if you have this one
Check for serial numbers MP95A9F6B001, MP95A9F6A001, or MP95A8F5A001 on the device. The product is part of the FDR Visionary Suite X-ray system with model CH-200.
- Brand
Fujifilm Medical Systems- Product
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for the serial numbers MP95A9F6B001, MP95A9F6A001, or MP95A8F5A001 on the device.
How this recall unfolded
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0232-2018 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0232-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.