Z-2106-2019 Class II Terminated

Recalled by Comet Technologies Usa Inc — Shelton, CT

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
October 1, 2018
Termination Date
June 13, 2024
Voluntary/Mandated
FDA Mandated
Product Quantity
93

Product Description

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

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution

Code Information

X-Ray Systems