SEDECAL SA: Model Number SM-40HF-B-D-C; 40KW 70C READY, 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 70C READY, 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 08436046001510, Serial Numbers: G37158, G61698, G62863, G41192, G62814, G41098, G62566, G60400, G63392, G60406.
- Product quantity
- 10 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Algete
- Country
- Spain
- Event id
- 97075
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