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U.S. Department of Health and Human Services

Class 2 Device Recall Laser engraving, cutting, and marking machine.

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 Class 2 Device Recall Laser engraving, cutting, and marking machine.see related information
Date Initiated by FirmAugust 08, 2024
Date PostedDecember 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0524-2025
Recall Event ID 95757
Product Classification Laser marker or engraver, industrial or commercial - Product Code RHK
ProductFusion Pro 24, Model 17000
Code Information Model 17000 Product Report Accession Number: 2021046-000
FEI Number 3003468623
Recalling Firm/
Manufacturer		 Epilog Laser Corp.
16371 Table Mountain Pkwy
Golden CO 80403-1826
For Additional Information ContactZachary Steadman
303-277-1188
Manufacturer Reason
for Recall		a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionThe measures to be taken to repair such defect or to bring the product into compliance with the Federal standard. This Recall provides corrections by repair to a defective safety interlock location by a kit with comprehensive instructions, offered at no cost to purchasers
Quantity in Commerce751
DistributionUS Nationwide Distribution
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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