FDAHealthJune 10, 2025
SEDECAL SA — Model Number 40KWFXPLUS-710CW.007, 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 Number 40KWFXPLUS-710CW.007, Mobile X-ray system
- Brand
- SEDECAL SA
- Lot code
- UDI/DI 08436046002166, Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053.
Additional details
UDI/DI 08436046002166, Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 units.
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