Class II

Medical Device Recall: Model Number SM-40HF-B-D-C; 40KW 55C/60C, 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

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0270-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.