Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0524-2025Class II

Fusion Pro 24, Model 17000

Epilog Laser Corp. / initiated 2024-08-08 / Open, Classified

Epilog Laser Corp. began a recall of Fusion Pro 24, Model 17000 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0524-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Epilog Laser Corp.
Product
Fusion Pro 24, Model 17000
Product code
RHK Laser Marker Or Engraver, Industrial Or Commercial
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.
FDA root cause
Radiation Control for Health and Safety Act
Action
The measures to be taken to repair such defect or to bring the product into compliance with the Federal standard. This Recall provides corrections by repair to a defective safety interlock location by a kit with comprehensive instructions, offered at no cost to purchasers
Quantity in commerce
751
Distribution
US Nationwide Distribution
Product codes and lots
Model 17000 Product Report Accession Number: 2021046-000

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0524-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0524-2025Class IIOngoingFDA Mandated