Events

Recall of OCS2 OJEMANN CORTICAL STIMULATOR

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
    31353
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-20
  • 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
    Areas of current design are not compliant with iec-60601-1. if headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage comes in contact with outer case of unit voltage could be transmitted to patient.

Device

OCS2 OJEMANN CORTICAL STIMULATOR
  • Model / Serial
    Model Catalog: OCS2 (Lot serial: ALL LOTS)
  • Product Description
    Integra Ojemann Cortical Stimulator OCS2
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.