· Published by Health Canada · Official notice
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DermaV | Not applicable. | 1011600210 |
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.