Health product recall

SOLTIVE™ Premium SuperPulsed TF Laser System

Brand(s)
Last updated

Summary

Product
SOLTIVE™ Premium SuperPulsed TF Laser System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
SOLTIVE™ Premium SuperPulsed TF Laser System All lots. TFL-PLS

Issue

As part of Olympus' post market surveillance of SOLTIVE™ laser use, including a review of customer complaints and adverse events, we have become aware that some clinicians are defaulting to the preset laser values for all clinical procedures when that is not consistent with the instructions for use. Olympus is reminding users that preset treatment parameters may not be appropriate for all patients and are guidelines only. Olympus is sending this reminder after reviewing twenty-eight (28) complaints reported between 2021 to 2023 related to ureteral stone procedures, that described serious injuries.

Recall start date: February 5, 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-75158

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