Health product recall

Cyanosure DermaV Laser System

Last updated

Summary

Product
Cyanosure DermaV Laser System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

DermaV

Not applicable.

1011600210

Issue

Cynosure Lutronic has identified a adverse trend of complaint reports in North America for spark and loud noise resulting in patient burns during vascular treatment with the DermaV laser system. There is a remote possibility that utilizing higher fluences at 1064 nm wavelength with the current cryogen parameters can result in a spark/loud noise being observed during treatment that could potentially result in patient burn.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Cynosure Lutronic Technology Corporation

55, Samwon-Ro, Deogyang-Gu, Goyang-Si, Gyeonggi-Do, South Korea, 10550

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-82528

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