BEUDAMED
    FDA Recall Open, Classified

    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    Recall: Z-2587-2023 · Initiated August 15, 2023

    Recall

    Recall Number
    Z-2587-2023
    Event Number
    92901
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
    FEI Number
    3002807880
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 15, 2023
    Posted
    September 14, 2023

    Description

    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    Reason

    A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

    Action

    US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.

    Distribution

    Worldwide distribution

    Quantity

    19,115 systems