BEUDAMED
    FDA Recall Terminated

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    Recall: Z-1030-2013 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1030-2013
    Event Number
    64665
    Firm
    Integra Burlington MA, Inc.
    FEI Number
    1000120652
    Product Code
    GYC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 18, 2013
    Posted
    April 1, 2013
    Terminated
    February 25, 2014
    Address
    22 Terry Ave, Burlington, MA, 01803-2516

    Description

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    Reason

    If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.

    Action

    Integra initiated a voluntary recall on March 18, 2013 by providing written notification to consignees either by traceable courier service or traceable emails regarding the correction that Integra records indicate have an OCS2 since it was introduced to the market in 2007. The consignee notification: Advised of the nature of the issue and to immediately stop using the headphone jack while using the OCS2. Requested identification by S/N any OCS2's they have, and complete / return the Acknowledgment Return Form. Advised that Integra will contact the consignee to schedule a time / date to correct the OCS2's they have identified. Questions, contact service hotline at 1-888-772-7378.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.

    Quantity

    371 units