Class II
Medical Device Recall: SM_40HF_B_D_VIR3, Mobile X-ray system
SEDECAL SA · June 10, 2025
Reason for Recall
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.
Distribution
US: CA, IL, and NJ
States Affected
CA, IL, NJ
Quantity Affected
17 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0284-2026
Status: ongoing
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