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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 13, 2025
Date PostedJune 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1942-2025
Recall Event ID 97035
Product Classification Cabinet x-ray, industrial - Product Code RCE
ProductAmi HTX.
Code Information Accession number 2510780-000
Recalling Firm/
Manufacturer		 Spectral Instruments Inc
420 N Bonita Ave
Tucson AZ 85745-2747
Manufacturer Reason
for Recall		The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSent packets by Fed-Ex, containing corrected physical labels to all affected customers who possess either Lago X or AMI HTX instruments shipped before 01/01/2025.
Quantity in Commerce34
DistributionUS
Total Product Life CycleTPLC 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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