Recall archive / FDA device enforcement
SM_40HF_BDC3, Mobile X-ray system — FDA record Z-0287-2026
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 Jun 10, 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
- SM_40HF_BDC3, Mobile X-ray system
- Reason
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Classification
- Class II
- Recalling firm
- SEDECAL SA
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0287-2026
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 | UDI/DI 08436046001510, Serial Numbers: G41213 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA, IL, and NJ
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 29, 2025
- Recall initiation date
- Jun 10, 2025
- Center classification date
- Oct 23, 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.