BEUDAMED
    FDA Enforcement Class II Ongoing

    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

    Recall: Z-1166-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1166-2023
    Event ID
    91649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 1, 2023
    Initiation Date
    December 21, 2022
    Classification Date
    February 23, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

    Reason

    Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

    Code Info

    UDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734

    Distribution

    US Nationwide distribution.

    Quantity

    1 unit; Expanded Recall: 25 units