BEUDAMED
    FDA Recall 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 · Initiated August 20, 2020

    Recall

    Recall Number
    Z-2925-2020
    Event Number
    86272
    Firm
    Brainlab AG Olof-palme-str. 9 Munich Germany
    FEI Number
    3002619595
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 20, 2020
    Terminated
    May 13, 2021

    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.

    Action

    Brainlab will be distributing the Medineering Field Safety Notice / Product Notification CAPA-17 to the consignees via email. Instruction for user on how to effectively avoid the situation of risk to occur (i.e. how to avoid the described potential risk), please also refer to the Corrective action by the user section of the Medineering Field Safety Notice / Product Notification CAPA-17. 1. Please identify all Positioning Arms with the specified serial numbers 2. Especially when the arm is freestanding and unsupported, ensure that the Positioning Arm is not above the patient or the user. 3. Avoid unfavorable positions of the Positioning Arm. Examples of these can be found in the instructions or use in the payload test section. 4. Check the secure hold after each arm alignment.

    Distribution

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

    Quantity

    21 arms