Reported Oct 15, 2025 · Ongoing
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FUJIFILM Healthcare Americas Corporation · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- FDR Visionary Suite
- CH-200 Model/Version Numbers
(1) 566-16130-23(2) 566-16130-31(3) 566-16130-33
- Lot codes and dates
- Model/Version Number
(1) 566-16130-23(2) 566-16130-31(3) 566-16130-33
- UDI-DI
(1) 04540217052226(2) 04540217057436(3) 04540217057450
- Serial Numbers
(1) MP95A8F5A001MP95A9F6A001MP95A9F6B001MP95A9F74001MP95A9F74002MP95A9F76001MP95A9F78001(2) MP95AA783001(3) MP95AA983001MP95AA983002MP95AA983003MP95AA985001MP95AA985003MP95AA985002MP95AA988001MP95AA988002
- Model/Version Number
- Amount recalled
- 16 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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