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Soltive laser fibers

Official notice

28 May 2025

Last checked

28 May 2025

High riskHealth Canada

An official Health Canada notice concerns Soltive laser fibers. 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 Published 2025-05-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77514

Official notice

2025-05-28

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77514

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Affected products

Product 1

Affected products - Soltive Laser Fibers, Lot or serial number - All lots., Model or catalogue number - TFL-FBX150BS TFL-FBX200BS

Product 2

Affected products - Soltive Laser Fibers, Lot or serial number - All lots., Model or catalogue number - TFL-CSLU TFL-SLS

Product 3

Affected products - Soltive Laser Fibers, Lot or serial number - All lots., Model or catalogue number - TFL-FBX550R TFL-FBX150R TFL-FBX940R TFL-FBX200R TFL-FBX365R

Product 4

Affected products - Soltive Laser Fibers, Lot or serial number - All lots., Model or catalogue number - TFL-FBX550S TFL-FBX150S TFL-FBX200S TFL-FBX365S TFL-FBX940S

Product 5

Affected products - Soltive Laser Fibers, Lot or serial number - All lots., Model or catalogue number - TFL-CPLU TFL-PLS

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Soltive Laser Fibers.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

high

Recall details

Recall number

77514

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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