Skip to content
Recall Observatory FDA recall evidence

Device product

OMTech Desktop Laser Engraver

Z-2129-2024

June 07, 2024

Class II

Product summary

Firm
Rygel Advanced Machines d/b/a Omtech Laser
Event
Event 94785
Status
Ongoing
Classification
Class II
Quantity
641
Official record key
device-enforcement:Z-2129-2024

Official wording

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

Code information: Model: DF0812-40BG, USB-032B-U1

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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