Events

Recall of SHOCKPULSE LITHOTRIPSY 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
    78712
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-01
  • 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
    Revised labeling- the rating label on the back of the ultrasonic generator specifies a voltage range of 100v to 240 v and based on tests this needs to be revised to 100v to 150 v.

Device

SHOCKPULSE LITHOTRIPSY GENERATOR
  • Model / Serial
    Model Catalog: SPL-G (Lot serial: CG0158); Model Catalog: SPL-G (Lot serial: CG0032); Model Catalog: SPL-G (Lot serial: CG0059); Model Catalog: SPL-G (Lot serial: CG0131); Model Catalog: SPL-G (Lot serial: CG0129)
  • Product Description
    Shockpulse lithotropsy generator
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.