BEUDAMED
    FDA Enforcement Class II Ongoing

    DigitalDiagnost C50 1.1

    Recall: Z-1563-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1563-2022
    Event ID
    90728
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    August 31, 2022
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    DigitalDiagnost C50 1.1

    Reason

    Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

    Code Info

    Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

    Distribution

    Nationwide Distribution including Puerto Rico

    Quantity

    11 systems (updated 1/3/2023)