BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1416-2023 · Initiated February 20, 2023

    Recall

    Recall Number
    Z-1416-2023
    Event Number
    91806
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
    FEI Number
    3002807880
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 20, 2023
    Posted
    April 20, 2023

    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.

    Action

    A recall notification letter was issued February 20, 2023. The Urgent Medical Device Correction letter includes the following instructions for the Customer: " Stop using SmartPerfusion and 2D Perfusion. NOTE: This message does not impact (other parts of) the Philips Allura or Azurion systems or other tools within the Interventional Workspot. The Philips Allura and Azurion systems as well as other Interventional Workspot tools may continue to be used. " Place the Urgent Medical Device Correction Letter with the documentation of the system. " Circulate the notice to all users so that they are aware of the product issue. " Return the reply form attached to the Urgent Medical Device Correction letter to Philips to confirm that the users of the system have reviewed and understood it.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    1461 units (236 US, 1225 OUS)