Class II

Medical Device Recall: Portable X-ray system

DIGIMED CO., LTD · June 19, 2025

Reason for Recall

Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

Distribution

US

Quantity Affected

530

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2117-2025

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.

DIGIMED CO., LTD Medical Device Recall: Portable X-ray system | SafeCheck