FDAHealthJune 10, 2025
SEDECAL SA — Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
⚠️ 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.
Is this relevant to me?
- Geography
- US, CA, IL, NJ
- Source agency
- FDA
- Category
- Health
- Published
- June 10, 2025
US: CA, IL, and NJ
What's affected?
- Product
- Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
- Brand
- SEDECAL SA
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 22 units.
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