BEUDAMED
    FDA Recall Terminated

    One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.

    Recall: Z-0901-2011 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-0901-2011
    Event Number
    57377
    Firm
    Bunnell, Inc.
    FEI Number
    3032745446
    Product Code
    LSZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 25, 2010
    Posted
    January 14, 2011
    Terminated
    April 17, 2012
    Address
    436 Lawndale Dr, Salt Lake City, UT, 84115-2917

    Description

    One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.

    Reason

    Product software coding error may compromise patient safety.

    Action

    Customers were notified by an "Urgent: Medical Device Recall or Correction" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade.

    Distribution

    Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.

    Quantity

    660 total