Events

Recall of CYBERWAND DUAL ULTRASONIC LITHOTRIPSY SYSTEM - GENERATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    26974
  • Event Risk Class
    III
  • Event Initiated Date
    2011-03-14
  • 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
    A version of software associated with the cyberwand may cause sub-optimal performance such that the device fragments stones at a slower rate than is normally expected.

Device

CYBERWAND DUAL ULTRASONIC LITHOTRIPSY SYSTEM - GENERATOR
  • Model / Serial
    Model Catalog: CW-USLG (Lot serial: GAXXXXXXX0001 to GAXXXXXXX0226); Model Catalog: CW-USLS (Lot serial: GAXXXXXXX0001 to GAXXXXXXX0226)
  • Product Description
    CYBERWAND DUAL ULTRASONIC LITHOTRIPSY
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.