SEDECAL SA: Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- SEDECAL SA
- Product
- Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US: CA, IL, and NJ
- Recall initiated
- 2025-06-10
- Code info
- UDI/DI unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165.
- Product quantity
- 27 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Algete
- Country
- Spain
- Event id
- 97075
Free daily digest + "My products" watchlist