FDA-Device2024-06-05Class II
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 Number: 566-16130-23 566-16130-33
FUJIFILM Healthcare Americas Corporation
Hazard
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Sold states
US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Affected count
18 units
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
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 Number: 566-16130-23 566-16130-33
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1898-2024Don't want to check this manually?
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