Medical device recalls Moderate risk

DIGIMED CO., LTD recalls Portable X-ray system

Recall date
June 19, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2117-2025
FDA classification
Class II
Brand / firm
DIGIMED CO., LTD
Sold / distributed
US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Portable X-ray system

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