FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2024 - (Recall #: Z-1898-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 11, 2024

Date Posted: June 5, 2024

Recall Number: Z-1898-2024

Event ID: 94443

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

Status: Ongoing

Product Quantity: 18 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated