BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): 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 arm.

    Recall: Z-2207-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2207-2012
    Event ID
    62650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 25, 2012
    Classification Date
    August 15, 2012
    Termination Date
    March 1, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    Description

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): 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 arm.

    Reason

    Essenta DR C-Arm may fall

    Code Info

    Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050

    Distribution

    Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.

    Quantity

    7 units