BEUDAMED
    FDA Enforcement Class II Terminated

    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.

    Recall: Z-2500-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2500-2018
    Event ID
    80402
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    July 24, 2018
    Termination Date
    July 3, 2024
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.

    Reason

    The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.

    Code Info

    Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5

    Distribution

    US Nationwide Distribution

    Quantity

    459 affected systems