FDA Recall Open, Classified

OMTech Desktop Laser Engraver

Recall: Z-2129-2024 · Initiated June 7, 2024

Recall

Recall Number
Z-2129-2024
Event Number
94785
Firm
Rygel Advanced Machines d/b/a Omtech Laser
FEI Number
3022117867
Product Code
RIM
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
June 7, 2024
Posted
June 14, 2024
Address
1150 N Red Gum St, Anaheim, CA, 92806-2530

Description

OMTech Desktop Laser Engraver

Reason

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

Action

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.

Distribution

US Nationwide

Quantity

641