Stop using nowMedical device recall · FDA · Published April 11, 2024
FUJIFILM FDR Visionary Suite: Tube Rupture Risk in Skull/Spine Imaging
FUJIFILM recalls specific FDR Visionary Suite models for potential tube rupture causing patient injury during skull or spine imaging. Affected units have unique serial numbers and model numbers listed in the recall notice.
FUJIFILM is recalling certain FDR Visionary Suite medical imaging devices that could have bolts failing under stress, potentially causing the tube support to fall and injure patients during skull or spine imaging. This recall is important because the failure could lead to serious harm if the device malfunctions during use. Read more at govinfonow.com/recall/55411-fujifilm-fdr-visionary-suite-tube-rupture-risk-in-skull-spine.
“FUJIFILM FDR Visionary Suite: Tube Rupture Risk in Skull/Spine Imaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55411-fujifilm-fdr-visionary-suite-tube-rupture-risk-in-skull-spine. Based on FDA recall #Z-1898-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1898-2024%22&limit=1).
The FDA announced on April 11, 2024, that FUJIFILM Healthcare Americas Corporation is recalling the FDR Visionary Suite CH-200 X-ray device due to bolts that may rupture. This hazard could cause the tube support to fall and result in patient injury.
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, which could result in patient injury.
Context
GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has had 13 other recalls since October 14, 2021. Other recent recalls of similar products include Shimadzu Ceiling X-Ray Tube Support Models CH-200/CH-200M Recall (October 16, 2025) and Canon Alphenix INFX-8000F X-Ray System Recall (December 19, 2025).
How to tell if you have this one
Check for the model numbers 566-16130-23 or 566-16130-33 and serial numbers listed in the recall notice. The device is used for generating digital or conventional radiographic images of the skull, spinal column, chest, abdomen, or extremities.
Brand
FUJIFILM Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the device if it has the model numbers or serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Florida, Illinois, Nebraska, New Hampshire, Ohio, Tennessee, Wisconsin.
Recall timeline
FDA published this recall 55 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-1898-2024 (April 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1898-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.