CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Fusion Pro recalled by Epilog Laser
Epilog Laser is recalling Fusion Pro 24, distributed nationwide in the US. The recall was initiated on 8 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0524-2025
- FDA event ID
- 95757
- Recalling firm
- Epilog Laser, Golden, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2024
- FDA classified
- 3 Dec 2024
- Reported
- 11 Dec 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Aug 2024 | Recall initiated by company | |
| 3 Dec 2024 | Classified by FDA | +117 days |
| 11 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Fusion Pro 24, Model 17000
Where it was distributed
US Nationwide Distribution
Questions about this recall
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.
Which lots are affected?
Model 17000 Product Report Accession Number: 2021046-000
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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