Events

Field Safety Notices about LightSheer DESIRE XC handpiece

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Lumenis.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-03-25
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Device software treatment preset parameters do not match the operator manual, and exceed recommended settings. operator manual parameters are lower than indicated for specific hair color and fitzpatrick skin type resulting in insufficient treatment effect. experienced device operators who have an understanding of fitzpatrick skin typing, hair removal parameter selection and lightsheer products will likely note the higher than expected treatment settings displayed by the system for the xc treatment handpiece. if the device operator references existing lightsheer desire operator manual the settings noted will be lower than expected. selecting settings from the desire operator manual would result in no or low treatment effect.

Device

LightSheer DESIRE XC handpiece
  • Model / Serial
  • Manufacturer
    Lumenis

Manufacturer

Lumenis