Z-0524-2025 Class II Ongoing
FDA device recall Z-0524-2025 was initiated by Epilog Laser Corp. on August 8, 2024 and is designated Class II. Reason for recall: 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 t… The recall status is ongoing. Affected quantity: 751.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- August 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 751
Product Description
Fusion Pro 24, Model 17000
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model 17000 Product Report Accession Number: 2021046-000