Recall archive / FDA device enforcement
Portable X-ray system — FDA record Z-2117-2025
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 Jun 19, 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
- Portable X-ray system
- Reason
- Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- Classification
- Class II
- Recalling firm
- DIGIMED CO., LTD
- Quantity
- 530
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2117-2025
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 | UDI-DI/Model Name: 08800021800014/DIOX-602 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 30, 2025
- Recall initiation date
- Jun 19, 2025
- Center classification date
- Jul 18, 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.