BEUDAMED
    FDA Enforcement Class II Ongoing

    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

    Recall: Z-1327-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1327-2022
    Event ID
    90490
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems DMC GmbH
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    May 19, 2021
    Classification Date
    July 12, 2022
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24-26, Hamburg, N/A, Germany

    Description

    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

    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 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. (Updated 1/30/23) 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 712032 Serial Numbers - 10001088 10001097 10001104 10001112 19000317 10001095 10001102 10001105

    Distribution

    US Nationwide Distribution

    Quantity

    140 systems in total, (Updated 1/30/2023).