BEUDAMED
    FDA Enforcement Class II Terminated

    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

    Recall: Z-0893-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0893-2022
    Event ID
    89790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 11, 2022
    Classification Date
    April 7, 2022
    Termination Date
    April 14, 2023
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60192-2061, United States

    Description

    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

    Reason

    There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

    Code Info

    A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)

    Distribution

    Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

    Quantity

    7 devices