BEUDAMED
    FDA Recall Terminated

    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    Recall: Z-0716-2018 · Initiated January 4, 2018

    Recall

    Recall Number
    Z-0716-2018
    Event Number
    79099
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 4, 2018
    Posted
    February 24, 2018
    Terminated
    October 9, 2019
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    Reason

    There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may also generate a peculiar burning smell that may be noticed. In some instances this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality is reduced.

    Action

    Customer Notification letter dated August 2017 were sent to affected customers. The letter identified affected product, problem and actions to be taken. The customer is requested to place this Field Safety Notice with the documentation of the system until this correction has been implemented. For questions contact your local Philips representative.

    Distribution

    Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.

    Quantity

    705