BEUDAMED
    FDA Recall Terminated

    Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

    Recall: Z-0872-2015 · Initiated October 31, 2014

    Recall

    Recall Number
    Z-0872-2015
    Event Number
    69873
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 31, 2014
    Posted
    December 24, 2014
    Terminated
    February 7, 2017
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    Description

    Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

    Reason

    The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

    Action

    The firm initiated a recall in Europe by notification to the regulatory authority on 10/31/2014. The firm will initiate a recall in the United States on 12/03/14 by distributing a customer notification letter.

    Distribution

    The product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.

    Quantity

    138,446 units distributed globally