BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0765-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0765-2016
    Event ID
    72571
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    November 3, 2015
    Classification Date
    February 5, 2016
    Termination Date
    August 19, 2016
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    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).

    Code Info

    Ceiling version only.

    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