Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system — recall Z-0278-2026
U.S. FDA — Device Enforcement · Spain · 2025-06-10 · Class II
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Reported risk: 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.
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