Health product recall

Soltive Laser System

Brand(s)
Last updated

Summary

Product
Soltive Laser System
Issue
Medical devices - Device compatibility
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 Premium Superpulsed Laser System

All lots.

TFL-PLS

Soltive Wired Footswitch

All lots.

TFL-AFSW

Soltive Wireless Footswitch

All lots.

TFL-AFSWL

Issue

Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser.

Recall start date: June 28, 2024

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-75813

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