Events

Recall of PURE SYSTEM

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

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
    66908
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-06
  • 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
    Clarion medical is voluntarily conducting a recall of the endymed pure system due to an advised error code traced to a potentially faulty main board. the issue results in the handpiece losing contact with the main board when connected to the system resulting in an error which results in the system not functioning.

Device

PURE SYSTEM
  • Model / Serial
    Model Catalog: ND_PRD00231 (Lot serial: All serial numbers)
  • Product Description
    EndyMed Pure System
  • Manufacturer
    ENDYMED MEDICAL LTD.

Manufacturer

ENDYMED MEDICAL LTD.
  • Manufacturer Address
    CAESAREA
  • Manufacturer Parent Company (2017)
    Endymed Ltd
  • Source
    HC