Date Initiated by Firm |
July 10, 2019 |
Create Date |
August 07, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2092-2019 |
Recall Event ID |
83438 |
Product Classification |
High-power laser light show projector - Product Code REA
|
Product |
ClubMax Laser Projection Series |
Code Information |
ClubMax 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 |
Quantity in Commerce |
1291 total |
Distribution |
Unknown |
Total Product Life Cycle |
TPLC Device Report
|
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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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