BEUDAMED
    FDA Recall Open, Classified

    Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    Recall: Z-2285-2026 · Initiated December 7, 2023

    Recall

    Recall Number
    Z-2285-2026
    Event Number
    98977
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis
    FEI Number
    3042175844
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 7, 2023
    Posted
    June 1, 2026
    Address
    6 Best Netherlands

    Description

    Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    Reason

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    Action

    Philips issued an IMPORTANT PRODUCT NOTICE to its consignees on 12/7/2023 via USPS mail. The notice explained the problem with the device and the circumstances under which if could occur and actions to be taken to minimize the effect of the problem. The notice further instructed the user to: - Keep this Important Product Notice with the documentation of the system until Philips corrects your system. - Circulate this notice to all users of the system so that they are aware of the issue. - Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Important Product Notice. For further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

    Distribution

    US Nationwide distribution.

    Quantity

    27 units