BEUDAMED
    FDA Enforcement Class II Ongoing

    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

    Recall: Z-1417-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1417-2023
    Event ID
    91806
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 26, 2023
    Initiation Date
    February 20, 2023
    Classification Date
    April 20, 2023
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

    Reason

    There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

    Code Info

    UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    549 units (75 US, 474 OUS)