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Recall Observatory FDA recall evidence

Device 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

Z-1898-2024

April 11, 2024

Class II

Product summary

Firm
FUJIFILM Healthcare Americas Corporation
Event
Event 94443
Status
Ongoing
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-1898-2024

Official wording

Reason: Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Code information: UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

Distribution pattern: US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury