Events

Recall of LUMICELL WAVE 6

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SILHOUET-TONE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25555
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Appareils non homologues pour la vente doit cesser jusqu'a l'obtention de la licence.

Device

LUMICELL WAVE 6
  • Model / Serial
    Model Catalog: 411365 (Lot serial: all); Model Catalog: 410233 (Lot serial: all); Model Catalog: 411423 (Lot serial: all); Model Catalog: 411421 (Lot serial: all); Model Catalog: 411400 (Lot serial: all); Model Catalog: 411508 (Lot serial: All); Model Catalog: 411520 (Lot serial: all); Model Catalog: 411321 (Lot serial: all); Model Catalog: 411370 (Lot serial: all); Model Catalog: 411681 (Lot serial: all); Model Catalog: 411310 (Lot serial: all); Model Catalog: 411422 (Lot serial: all); Model Catalog: 411512 (Lot serial: all); Model Catalog: 411476 (Lot serial: all); Model Catalog: 411108 (Lot serial: all); Model Catalog: 411690 (Lot serial: all)
  • Product Description
    LUMICELL WAVE 6;ENERGY 900;VERSALIS PEEL;SILVER PEEL;COMPU-LIFT;SOLI-TONE 2500;LMX;PR CELL 2G;LUMICELL TOUCH;DIAMOND TIPS;SLIM CONCEPT;ESSENTIAL PEEL;LIMINIX 920;DERMAPOD;VASCULYSE 2G RF;CRYSTAL FREE
  • Manufacturer
    SILHOUET-TONE CORPORATION

Manufacturer

SILHOUET-TONE CORPORATION