SEDECAL SA recalls SHIMADZU RF.004, Mobile X-ray system

Recall date

June 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0283-2026

FDA classification

Class II

Brand / firm

SEDECAL SA

Sold / distributed

US: CA, IL, and NJ

Why it was recalled

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.

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

What was recalled

SHIMADZU RF.004, Mobile X-ray system