Medical device recalls Moderate risk

Comet Technologies Usa Inc recalls YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and qualit…

Recall date
October 1, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2106-2019
FDA classification
Class II
Brand / firm
Comet Technologies Usa Inc
Sold / distributed
US Nationwide Distribution

Why it was recalled

Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.

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

What was recalled

YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

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