FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2025 - (Recall #: Z-0044-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 15, 2025

Date Posted: October 15, 2025

Recall Number: Z-0044-2026

Event ID: 97581

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 16 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated