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FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che
Recalled June 5, 2024 · FDA recall Z-1898-2024 · FUJIFILM Healthcare Americas
Hazard
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury · FDA Class II
Units
18 units
Sold at
US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Description
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Product
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
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →