BEUDAMED
    FDA Recall Open, Classified

    Incisive CT, software version 5.0

    Recall: Z-2520-2023 · Initiated August 2, 2023

    Recall

    Recall Number
    Z-2520-2023
    Event Number
    93000
    Firm
    Philips Healthcare
    FEI Number
    3016860078
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 2, 2023
    Posted
    September 30, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    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.

    Action

    Philips will inform customers of the issue via an Electronic Product Radiation Defect notification. Philips will schedule an appointment with customers to install the software update.

    Distribution

    US Nationwide Distribution

    Quantity

    140 systems