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U.S. Department of Health and Human Services

Class 2 Device Recall Logolas Laser Projection Series

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  Class 2 Device Recall Logolas Laser Projection Series see related information
Date Initiated by Firm July 10, 2019
Create Date August 07, 2019
Recall Status1 Open3, Classified
Recall Number Z-2096-2019
Recall Event ID 83438
Product Classification High-power laser light show projector - Product Code REA
Product Logolas Laser Projection Series
Code Information Logolas Laser Projection Series
Recalling Firm/
Manufacturer		 Gk Photonics Inc
717 Ridge Dr
Glendale CA 91206-1752
Manufacturer Reason
for Recall		 The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Distribution Unknown
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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