Health Products

Cyanosure DermaV Laser System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Cyanosure DermaV Laser System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
DermaVNot 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.

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