FDA Medical devices recall ·
Fusion Pro 24, Model 17000 recall
- Recall number
- Z-0524-2025
- Date
- (initiated August 8, 2024)
- Company / brand
- Epilog Laser Corp.
16371 Table Mountain Pkwy, Golden, CO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 751
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Fusion Pro 24, Model 17000
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model 17000 Product Report Accession Number: 2021046-000
Distribution
US Nationwide Distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0524-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.