FDA Medical Device Recalls (openFDA)
Rygel Advanced Machines d/b/a Omtech Laser: OMTech Desktop Laser Engraver
- Recall number
- Z-2129-2024
- Recalling firm
- Rygel Advanced Machines d/b/a Omtech Laser
- Product
- OMTech Desktop Laser Engraver
- Status
- Open, Classified
- Initiated
- 2024-06-07
- Posted
- 2024-06-14
- Terminated
- not on file
- Reason
- Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- OMTech Laser intends to send a Important Safety Warning letter to each customer of the Product. The letter includes the following information: a. A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard. b. Instructions with respect to the use of the product pending the correction of the defect. c. A clear evaluation in nontechnical terms of the hazards reasonably related to the failure to comply. The letter also states OMTech Laser, at its own expense, will provide all necessary materials to repair the Product, including detailed service installation instructions, to each customer of the Product.
- Quantity
- 641
- Distribution
- US Nationwide
- Lot, serial or model codes
- Model: DF0812-40BG, USB-032B-U1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RIM
- Firm FEI
- 3022117867
- Firm city
- Anaheim
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28