BEUDAMED
    FDA Recall Open, Classified

    DigitalDiagnost C50 1.1

    Recall: Z-1563-2022 · Initiated February 25, 2022

    Recall

    Recall Number
    Z-1563-2022
    Event Number
    90728
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    KPR
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    February 25, 2022
    Posted
    September 1, 2022
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    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.

    Action

    Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377.

    Distribution

    Nationwide Distribution including Puerto Rico

    Quantity

    11 systems (updated 1/3/2023)