BEUDAMED
    FDA Recall Terminated

    Philips Healthcare DuraDiagnost X- Ray

    Recall: Z-1555-2015 · Initiated February 9, 2015

    Recall

    Recall Number
    Z-1555-2015
    Event Number
    70916
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    February 9, 2015
    Posted
    May 19, 2015
    Terminated
    June 14, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Healthcare DuraDiagnost X- Ray

    Reason

    The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

    Action

    Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892

    Distribution

    Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.

    Quantity

    3 DuraDiagnost