Events

Recall of STAR S4 IR EXCIMER LASER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMO CANADA COMPANY.

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
    84893
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-03
  • 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
    This recall is to address a potential issue where the buffer device component could incorrectly process the footswitch signal if power to the component device was lost through the manual tripping of a breaker. the incorrectly processes footswitch signal even though there is no operation interaction would potentially allow the laser to commence firing.

Device

STAR S4 IR EXCIMER LASER SYSTEM
  • Model / Serial
    Model Catalog: STAR S4 IR (Lot serial: >10 numbers contact mfg)
  • Product Description
    STAR S4 IR EXCIMER LASER SYSTEM
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY