Medical device recalls Moderate risk

Rygel Advanced Machines d/b/a Omtech Laser recalls OMTech Desktop Laser Engraver

Recall date
June 7, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2129-2024
FDA classification
Class II
Brand / firm
Rygel Advanced Machines d/b/a Omtech Laser
Sold / distributed
US Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OMTech Desktop Laser Engraver

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