Soltive Laser Fibers
Brand(s)
Last updated
Summary
Product
Soltive Laser Fibers
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Soltive Laser Fibers | All lots. | TFL-FBX150BS TFL-FBX200BS |
| Soltive Laser Fibers | All lots. | TFL-CSLU TFL-SLS |
| Soltive Laser Fibers | All lots. | TFL-FBX550R TFL-FBX150R TFL-FBX940R TFL-FBX200R TFL-FBX365R |
| Soltive Laser Fibers | All lots. | TFL-FBX550S TFL-FBX150S TFL-FBX200S TFL-FBX365S TFL-FBX940S |
| Soltive Laser Fibers | All lots. | TFL-CPLU TFL-PLS |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77514
Get notified
Receive emails about new and updated recall and safety alerts.