Home / Recalls / Medical Devices
SEDECAL SA recalls SM_40HF_B_D_VIR3.004, Mobile X-ray system
Recalled October 29, 2025 · FDA recall Z-0285-2026 · 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
3 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
SM_40HF_B_D_VIR3.004, Mobile X-ray system
Manufacturer(s)
SEDECAL SA
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →