SEDECAL SA — Model Number SM-40HF-B-D-C; 40KW 50G, 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 SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
- Brand
- SEDECAL SA
- Lot code
- UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.
Additional details
UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 39 units.
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