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U.S. Department of Health and Human Services

Class 2 Device Recall OMTech Laser

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 Class 2 Device Recall OMTech Lasersee related information
Date Initiated by FirmJune 07, 2024
Date PostedJune 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2129-2024
Recall Event ID 94785
Product Classification Laser marker, cutter, or engraver, tabletop, consumer - Product Code RIM
ProductOMTech Desktop Laser Engraver
Code Information Model: DF0812-40BG, USB-032B-U1
Recalling Firm/
Manufacturer		 Rygel Advanced Machines d/b/a Omtech Laser
1150 N Red Gum St
Anaheim CA 92806-2530
Manufacturer Reason
for Recall		Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionOMTech Laser intends to send a Important Safety Warning letter to each customer of the Product. The letter includes the following information: a. A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard. b. Instructions with respect to the use of the product pending the correction of the defect. c. A clear evaluation in nontechnical terms of the hazards reasonably related to the failure to comply. The letter also states OMTech Laser, at its own expense, will provide all necessary materials to repair the Product, including detailed service installation instructions, to each customer of the Product.
Quantity in Commerce641
DistributionUS Nationwide
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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