BEUDAMED
    FDA Recall Terminated

    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

    Recall: Z-0765-2016 · Initiated November 3, 2015

    Recall

    Recall Number
    Z-0765-2016
    Event Number
    72571
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 3, 2015
    Posted
    February 5, 2016
    Terminated
    August 19, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

    Reason

    Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

    Action

    The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.

    Distribution

    Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.

    Quantity

    2 subject to correction and removal