Recall archive / FDA device enforcement
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. I... — FDA record Z-0781-2024
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 Dec 13, 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
- Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
- Reason
- Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
- Classification
- Class II
- Recalling firm
- SEDECAL SA
- Quantity
- 845 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0781-2024
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 | All serial numbers, UDI-DI 08436046002500. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to AL, FL, and NC. There was no military/government distribution.
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
- Jan 31, 2024
- Recall initiation date
- Dec 13, 2023
- Center classification date
- Jan 22, 2024
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.