BEUDAMED
    FDA Recall Terminated

    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079

    Recall: Z-1809-2020 · Initiated April 3, 2020

    Recall

    Recall Number
    Z-1809-2020
    Event Number
    85399
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 3, 2020
    Posted
    April 29, 2020
    Terminated
    February 1, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079

    Reason

    When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

    Action

    Philips Healthcare issued Urgent Medical Device Correction letter via Field Action 2020-IGTBST-003 issued on April 3, 2020. Letter states reason for recall, health risk an action to take: To avoid this hazardous situation, the users should: BY CUSTOMER/ USER " Use XperGuide live guidance with the L-arm positioned in the XperCT scan position. " Move the L-arm back to the initial XperCT scan position if the system displays the warning Live 3D roadmap not possible. Please move stand to the : [acquisition position] position. At any stage during needle guidance, the user can perform a verification run to verify if the needle position is correct. Please ensure that all staff working with the XperGuide application are informed of the content of this letter and place a copy of this letter as an addendum to the Instructions for Use. Questions contact your local Philips representative. Technical Support Line: 1-800-722-9377. Philips will resolve the problem for all affected systems by installing a new Interventional Workspot software release. This action will start in April 2020. Expanded Recall 12-22-20: The two systems for the Netherland have already been corrected through the implementation of software update. For the system in Germany, the Customer has been notified through the Field Safety Notice.

    Distribution

    Worldwide distribution. US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands New Zealand, South Africa, Switzerland, Thailand

    Quantity

    22 units (6 US and 16 OUS); Expanded 3units; Total: 25