Events

Recall of INTEGRE PRO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARION MEDICAL TECHNOLOGIES INC..

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
    24034
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-17
  • 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
    Under certain conditions there is a potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics. if this occurs there is a remote possibility the user could be exposed to any diffused reflected laser light during laser treatment.

Device

INTEGRE PRO
  • Model / Serial
    Model Catalog: LP5532 (Lot serial: SN # 5A2058); Model Catalog: LP5532 (Lot serial: SN # 5A2067)
  • Product Description
    ELLEX INTEGRA PRO LP5532
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.