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Recall Observatory FDA recall evidence

Device product

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Z-0044-2026

September 15, 2025

Class II

Product summary

Firm
FUJIFILM Healthcare Americas Corporation
Event
Event 97581
Status
Ongoing
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-0044-2026

Official wording

Reason: It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Code information: Model/Version Number: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33; UDI-DI: (1) 04540217052226, (2) 04540217057436, (3) 04540217057450; Serial Numbers: (1) MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, (2) MP95AA783001, (3) MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;

Distribution pattern: Domestic: AK, CA, FL, IL, MA, NH, OH, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.