Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

OMTech Desktop Laser Engraver

FDA Recall Z-2129-2024 · Posted 2024-06-14

Recalling FirmRygel Advanced Machines d/b/a Omtech Laser
Recall StatusOpen, Classified
Product CodeRIM
Date Initiated2024-06-07
Product Quantity641

Reason for Recall

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑