BEUDAMED
    FDA Enforcement Class II Terminated

    Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)

    Recall: Z-2925-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2925-2020
    Event ID
    86272
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 9, 2020
    Initiation Date
    August 20, 2020
    Classification Date
    August 29, 2020
    Termination Date
    May 13, 2021
    Address
    Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)

    Reason

    Holding force of the Positioning Arm can be reduced by prolonged non-use.

    Code Info

    Article Number: 56000-01B, Description: CIRQ ARM SYSTEM 1.3.2, Serial numbers: 20100132017 20100132019 20100132020 20100132022 20100132023 20100132026 20100132028 20100132030 20100132031 20100132033 20100132035 20100132036 20100132037 20100132038 20100132039 Article Number: 56000-01C, Description:CIRQ ARM SYSTEM 1.4, Serial numbers: 20100140052 20100140053 20100140054 20100140055 20100140056 20100140057

    Distribution

    USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom

    Quantity

    21 arms