BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT, software version 5.0

    Recall: Z-2520-2023 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2520-2023
    Event ID
    93000
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    August 2, 2023
    Classification Date
    September 29, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Incisive CT, software version 5.0

    Reason

    Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

    Code Info

    software version 5.0

    Distribution

    US Nationwide Distribution

    Quantity

    140 systems