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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 FirmJuly 24, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2940-2026
Recall Event ID 99631
Product Classification Cabinet x-ray, industrial - Product Code RCE
ProductAmi HTX
Code Information All serial numbers.
FEI Number 3002679892
Recalling Firm/
Manufacturer		 Spectral Instruments Inc
420 N Bonita Ave
Tucson AZ 85745-2747
Manufacturer Reason
for Recall		Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionCustomer notification letters dated August 21, 2023 and allows for scheduling of the software upgrade corrections.
Quantity in Commerce35
DistributionUnited States.
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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