BEUDAMED
    FDA Enforcement Class II Ongoing

    Cirq Arm System 2.0

    Recall: Z-1292-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1292-2023
    Event ID
    91781
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2023
    Initiation Date
    March 2, 2023
    Classification Date
    March 28, 2023
    Address
    Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    Cirq Arm System 2.0

    Reason

    Risk of mechanical instability due to potential manufacturing error of the device

    Code Info

    56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.

    Distribution

    Texas

    Quantity

    1 unit