Recall archive / FDA device enforcement
Phoenix mKDR, digital mobile diagnostic x-ray system — FDA record Z-1202-2023
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 Feb 6, 2023. 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
- Phoenix mKDR, digital mobile diagnostic x-ray system
- Reason
- Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- Classification
- Class II
- Recalling firm
- SEDECAL SA
- Quantity
- 53 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1202-2023
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 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Argentina, Panama
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Feb 6, 2023
- Center classification date
- Mar 2, 2023
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.