SEDECAL SA: SM_40HF_B_D_VIR3, 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
- SM_40HF_B_D_VIR3, 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 08436046002166, Serial Numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.
- Product quantity
- 17 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Algete
- Country
- Spain
- Event id
- 97075
Free daily digest + "My products" watchlist