Health product recall

Solea

Last updated

Summary

Product
Solea
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 catalogue number
Solea Serial number 0310523 MODEL 3.0

Issue

In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the armed state). However, there were reported events where the laser was activated in the armed state when the user did not actively depress the foot pedal.

Recall start date: August 24, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Convergent Dental, Inc.
140 Kendrick St., Needham, Massachusetts, United States, 02494
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74308