Summary
The FDA issued a Class II for Fusion Pro 24, Model 17000 by Epilog Laser Corp.. 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 f.
Details
Source
Device Recall
External ID
Z-0524-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
Fusion Pro 24, Model 17000
Lot/Code Info: Model 17000 Product Report Accession Number: 2021046-000
Quantity Affected: 751
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
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2024-08-08
Company
Golden, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Epilog Laser Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Epilog Laser Corp. have FDA actions?
This is the only FDA action we have on record for Epilog Laser Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0524-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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