BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.

    Recall: Z-0584-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0584-2014
    Event ID
    67012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2014
    Initiation Date
    December 5, 2013
    Classification Date
    December 27, 2013
    Termination Date
    January 17, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.

    Reason

    X-ray system C-arm casting may loosen and fall

    Code Info

    All Essenta DR x-ray Systems

    Distribution

    Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.

    Quantity

    424 units