BEUDAMED
    FDA Recall Terminated

    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

    Recall: Z-2793-2020 · Initiated July 16, 2020

    Recall

    Recall Number
    Z-2793-2020
    Event Number
    86046
    Firm
    Brainlab AG Olof-palme-str. 9 Munich Germany
    FEI Number
    3002619595
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 16, 2020
    Terminated
    July 27, 2021

    Description

    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

    Reason

    Incorrect manufacturer calibration

    Action

    1. Refer to the appendix for the list of Brainlab Curve or Kick Navigation Systems with an affected camera installed to determine if your navigation system is affected. 2. For Cranial or ENT navigation software in combination with an affected system camera installed: Do not use the Z-touch Laser Pointer for patient registration. Use other instruments with the standard instrument pivoting method for Surface Matching or Landmark Registration, or Automatic Image Registration (AIR) if available. 3. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning, in addition to the instructions on the registration verification page appearing in the Cranial or ENT software: Verify accuracy at multiple anatomical landmarks, especially in the region of interest, as it may differ from the accuracy verified on the skin surface. If the region of interest is not accessible, verify in areas as close as possible to the region of interest. 4. In order to avoid nuisance with Spine & Trauma 3D or Orthopedic Navigation software in combination with an affected system camera installed: Do not attempt to use the optional Disposable Clip-On Remote Control. For patient registration, acquire registration points with the standard instrument pivoting method; or for Spine & Trauma 3D use Automatic Image Registration (AIR) if available.

    Distribution

    USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

    Quantity

    9 unit