Recall Monitor
Health Products

Soltive Laser Fibers

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Soltive Laser Fibers
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Soltive Laser FibersAll lots.TFL-FBX150BS
TFL-FBX200BS
Soltive Laser FibersAll lots.TFL-CSLU
TFL-SLS
Soltive Laser FibersAll lots.TFL-FBX550R
TFL-FBX150R
TFL-FBX940R
TFL-FBX200R
TFL-FBX365R
Soltive Laser FibersAll lots.TFL-FBX550S
TFL-FBX150S
TFL-FBX200S
TFL-FBX365S
TFL-FBX940S
Soltive Laser FibersAll 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

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