BEUDAMED
    FDA Enforcement Class II Ongoing

    SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

    Recall: Z-1416-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1416-2023
    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

    SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

    Reason

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

    Code Info

    UDI: (01)00884838088566 SmartPerfusion 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 key: 459801530271 sw key SmartPerfusion

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    1461 units (236 US, 1225 OUS)