Soltive Laser Fibers
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Soltive Laser Fibers |
All lots. |
TFL-FBX150BS |
Soltive Laser Fibers |
All lots. |
TFL-CSLU |
Soltive Laser Fibers |
All lots. |
TFL-FBX550R |
Soltive Laser Fibers |
All lots. |
TFL-FBX550S |
Soltive Laser Fibers |
All lots. |
TFL-CPLU |
Issue
During clinical use, thermal incidents have the potential to occur while using the Soltive Laser Systems and fibers when laser energy is unintentionally redirected and scattered out of the laser fiber core through a fracture in the fiber. Users should carefully follow the instructions for use of the affected devices.
Recall start date: May 15, 2025
Additional information
Details
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
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