Health product recall

Soltive Superpulsed Laser Fiber Single Use

Brand(s)
Last updated

Summary

Product
Soltive Superpulsed Laser Fiber Single Use
Issue
Medical devices - Labelling and packaging
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 Superpulsed Laser Fiber Single Use

All lots.

TFL-FBX550S
TFL-FBX150S
TFL-FBX200S
TFL-FBX365S
TFL-FBX940S

Soltive Superpulsed Laser Ball Tip Fiber Single Use

All lots.

TFL-FBX150BS
TFL-FBX200BS

Issue

There are errors identified in the Soltive Single-use Laser Fiber instructions for use. Olympus conducted an internal review of the Soltive Single-use Fibers and identified inconsistencies in the IFU.

Recall start date: December 1, 2023

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-74736

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