FDA recall Z-2129-2024
Rygel Advanced Machines d/b/a Omtech Laser · Class II · device
Product
OMTech Desktop Laser Engraver
Reason for recall
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
Distribution
US Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2024-06-07
- Report date
- 2024-06-19
- Voluntary/Mandated
- FDA Mandated
- Location
- Anaheim, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2024