Recall archive / FDA device enforcement
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 — FDA record Z-0044-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
- 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.
- Classification
- Class II
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 16 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0044-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 15, 2025
- Recall initiation date
- Sep 15, 2025
- Center classification date
- Oct 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.