SEDECAL SA: Model SM-32HF-Batt; 32KW ANALOG, 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 SM-32HF-Batt; 32KW ANALOG, 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 08436046001466, Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244, G40196, G60461, G33309.
- Product quantity
- 22 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Algete
- Country
- Spain
- Event id
- 97075
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