Reported Jun 5, 2024 · Ongoing
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
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 - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations
- Model/Catalog Number566-16130-23 566-16130-33
- Lot codes and dates
- UDI-DI04540217052226 04540217057450
- S/N
MP95A9F6A001MP95A9F74002MP95A9F74001MP95AA983002MP95AA985001MP95AA985003MP95AA985002MP95AA988001MP95AA993001MP95AA996002MP95AA996001MP95AA997001MP95A9F6B001MP95A9F76001MP95AA983001MP95AA988002MP95AA98A001MP95AA993002
- Amount recalled
- 18 units
Where it was sold
Why it was recalled
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
This product could cause temporary or reversible health problems — stop using it.
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