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U.S. Department of Health and Human Services

Class 2 Device Recall vtomex L Series nondestructive testing cabinet xray systems

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  Class 2 Device Recall vtomex L Series nondestructive testing cabinet xray systems see related information
Date Initiated by Firm September 29, 2020
Create Date November 13, 2020
Recall Status1 Terminated 3 on May 02, 2023
Recall Number Z-0442-2021
Recall Event ID 86620
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product v|tome|x L Series non-destructive testing cabinet x-ray systems
Code Information v/tome/x L Series (L240, L300 or L450)
Recalling Firm/
Manufacturer		 Ge Inspection Technologies Llc
721 Visions Dr
Skaneateles Falls NY 13153-5314
Manufacturer Reason
for Recall		 It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Distribution USA Canada
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.
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