FDA Medical Device Recalls (openFDA)
Epilog Laser Corp.: Fusion Pro 24, Model 17000
- Recall number
- Z-0524-2025
- Recalling firm
- Epilog Laser Corp.
- Product
- Fusion Pro 24, Model 17000
- Status
- Open, Classified
- Initiated
- 2024-08-08
- Posted
- 2024-12-03
- Terminated
- not on file
- Reason
- a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The measures to be taken to repair such defect or to bring the product into compliance with the Federal standard. This Recall provides corrections by repair to a defective safety interlock location by a kit with comprehensive instructions, offered at no cost to purchasers
- Quantity
- 751
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model 17000 Product Report Accession Number: 2021046-000
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RHK
- Firm FEI
- 3003468623
- Firm city
- Golden
- Firm state
- CO
- 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