CanadaThe Cyanosure DermaV Laser System (model/catalogue number 1011600210) by Cynosure Lutronic Technology Corporation is affected and can be identified by the product name DermaV and the model/catalogue number 1011600210. Cynosure Lutronic identified an adverse trend of reports in North America of sparks and loud noises during vascular treatment when higher fluences at 1064 nm are used with the current cryogen parameters, which could potentially result in patient burns. Contact the manufacturer for additional information.
What's being recalled
Companies: Cynosure Lutronic Technology Corporation, 55, Samwon-Ro, Deogyang-Gu, Goyang-Si, Gyeonggi-Do, South Korea, 10550.
How to identify it
Affected products: DermaV; Lot or serial number: Not applicable.; Model or catalogue number: 1011600210
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)