FDA Device recall Z-0524-2025
Fusion Pro 24, Model 17000
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Fusion Pro 24, Model 17000 by Epilog Laser, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0524-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Epilog Laser |
| Distribution | US |
Product
Fusion Pro 24, Model 17000
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.
Identifiers
| code_info | Model 17000 Product Report Accession Number: 2021046-000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2025%22
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