Medical Device Recall: 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 routin
FUJIFILM Healthcare Americas Corporation · April 11, 2024
Reason for Recall
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Product Description
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
Distribution
US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
States Affected
NATIONWIDE
Quantity Affected
18 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1898-2024
Status: ongoing
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