Events

Recall of CUSA EXCEL+ SYSTEM - CONSOLE

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

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
    107102
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-15
  • 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
    The cusa excel family of ultrasonic tissue ablators are used in surgical procedures where fragmentation emulsification and aspiration of soft and hard tissue is desirable. the excel family of devices is tested against standard 60601 for electrical safety fire and mechanical hazard compliance by underwriters laboratory (ul) against european standard ul and canadian requirements. however the three excel consoles that have been imported and distributed in canada do not have the required specific ul canada logo.

Device

CUSA EXCEL+ SYSTEM - CONSOLE
  • Model / Serial
    Model Catalog: CUSA EXCEL2 (Lot serial: HFB1100401IE); Model Catalog: CUSA EXCEL2 (Lot serial: HFL1004101IE); Model Catalog: CUSA EXCEL2 (Lot serial: HFL1004701IE)
  • Product Description
    CUSA EXCEL + SYSTEM
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.