Recall Z-2129-2024— Rygel Advanced Machines d/b/a Omtech Laser
Class II · Ongoing
Class II FDA medical device recall by Rygel Advanced Machines d/b/a Omtech Laser, initiated 2024-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: OMTech Desktop Laser Engraver. Reason: Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2..
- Recalling firm
- Rygel Advanced Machines d/b/a Omtech Laser
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-07
- Firm location
- Anaheim, CA, United States
Product description
OMTech Desktop Laser Engraver
Reason for recall
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
Data sourced from openFDA. This site is unofficial and independent of the FDA.