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SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Recalled October 29, 2025 · FDA recall Z-0278-2026 · SEDECAL SA
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. · FDA Class II
Units
6 units
Sold at
US: CA, IL, and NJ
Description
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.
Product
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Manufacturer(s)
SEDECAL SA
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →