BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare DigitalDiagnost System X-Ray

    Recall: Z-1554-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1554-2015
    Event ID
    70916
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2015
    Initiation Date
    February 9, 2015
    Classification Date
    May 21, 2015
    Termination Date
    June 14, 2016
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Healthcare DigitalDiagnost System 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).

    Code Info

    Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2

    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

    54 DigitalDiagnost