Z-2129-2024 Class II Ongoing
FDA device recall Z-2129-2024 was initiated by Rygel Advanced Machines d/b/a Omtech Laser on June 7, 2024 and is designated Class II. Reason for recall: Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2. The recall status is ongoing. Affected quantity: 641.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- June 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 641
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.
Distribution Pattern
US Nationwide
Code Information
Model: DF0812-40BG, USB-032B-U1