OMTech Desktop Laser Engraver
This recall is currently active, issued June 14, 2024. It was issued by Rygel Advanced Machines D/B/A Omtech Laser.
- Recall Initiated
- June 7, 2024
- Posted
- June 14, 2024
- Recall Number
- Z-2129-2024
- Quantity
- 641
- Firm Location
- Anaheim, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
Distribution
US Nationwide
Lot / Code Info
Model: DF0812-40BG, USB-032B-U1
Root Cause
Radiation Control for Health and Safety Act
Action Taken
OMTech 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.