Lutronic DermaV Laser System Recalled for Potential Patient Burn Risk

Plain-English summary

Lutronic Corporation is recalling 1,065 units of the DermaV Laser System, a medical device that delivers pulsed laser energy at 532 nm and 1064 nm wavelengths. The recall is due to a safety hazard where utilizing higher fluences at the 1064nm wavelength with current cryogen parameters may result in a spark or loud noise during treatment. This malfunction can potentially result in a patient burn.

The affected units were distributed worldwide, including the United States, Canada, and the European Union. The specific units involved are identified by Model DermaV, Software Version 1.06, and UDI # 08800291820200. A list of specific serial numbers is available in the official recall documentation.

Healthcare providers and consumers should stop using the affected DermaV Laser Systems immediately. Users should contact Lutronic Corporation for instructions on how to return or repair the devices to prevent potential injury.

The recalled product

Product

Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epiderm

Manufacturer

Lutronic Corporation

Category

Medical Device — Laser System

Hazard

• burn-injury

Affected units

1,065

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls