BEUDAMED
    FDA Recall Open, Classified

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    Recall: Z-0874-2022 · Initiated February 2, 2022

    Recall

    Recall Number
    Z-0874-2022
    Event Number
    89787
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 2, 2022
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    Reason

    Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

    Action

    Urgent Medical Device Correction notification letters dated 2/2/22 were distributed to customers. 1. What is the problem and under what circumstances it can occur Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient. When the problem occurs, the area of the boosted images remains black, and the small X-ray viewer in the upper right corner will show a single static image of the previous run. The correct patient information is shown on the Philips Allura/ Azurion system. This defect is intermittent and is caused by a race condition when the software does not properly handle all the "process requests". This problem has been identified through the investigation of 2 (two) customer complaints. 2. What is the hazard/harm assoclated with this issue The incorrect image displayed to the user could lead to incorrect treatment. If the problem occurs, the Stent8oost Live application will have to be restarted (see action 4), causing a delay in the procedure. To date, Philips has not received any reports of harm associated with this problem. 3. Affected products and how to identify them The Philips StentBoost Live R2.0 used with Philips Allura and Azurion systems is affected by this issue. The software version of the Philips StentBoost Live application can be seen by clicking on the "About" box displayed when the application is opened (see Fig. 1 and 2).

    Distribution

    Global Distribution. US Nationwide.

    Quantity

    338