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U.S. Department of Health and Human Services

Class 2 Device Recall YXLON cabinet XRay System

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  Class 2 Device Recall YXLON cabinet XRay System see related information
Date Initiated by Firm October 01, 2018
Create Date August 07, 2019
Recall Status1 Open3, Classified
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 2		 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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