Class 2 Device Recall YXLON cabinet XRay System

• Date Initiated by Firm: October 01, 2018
• Create Date: August 07, 2019
• Recall Status: Terminated on June 13, 2024
• Recall Number: Z-2105-2019
• Recall Event ID: 83295
• Product Classification: Cabinet x-ray, industrial - Product Code RCE
• Product: YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
• Code Information: X-Ray Systems
• Recalling Firm/ Manufacturer: Comet Technologies Usa Inc; 100 Trap Falls Rd; Shelton CT 06484-4604
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: The firm sent a notification letter dated July 2019, to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that a service technician will be contacting you to schedule the retrofit service. For questions, call YXLON Service at (234) 284-7881.
• Quantity in Commerce: 77
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.