BEUDAMED
    FDA Recall Terminated

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    Recall: Z-1618-2020 · Initiated December 6, 2019

    Recall

    Recall Number
    Z-1618-2020
    Event Number
    85089
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    EQN
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 6, 2019
    Terminated
    July 1, 2022
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    Reason

    The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.

    Action

    On 12/6/2019 a "Urgent Medical device Correction" letter was sent to affected customers via mail. In addition, to providing information on the recall, the firm asked customers to take the following actions: 1. Please forward this Safety Information to the appropriate departments in your organization. 2. Please train your employees on the new Instructions for Use, especially chapter 5.1. 3. Please complete the attached acknowledgement form and return it to us. 4. If you have any questions about this communication, or needs additional copies of this Instruction for Use, please contact our Technical Support at 800-421-0837, Ext. 5350, Option 5.

    Distribution

    Worldwide distribution - US Nationwide and country of Canada.

    Quantity

    27,165 scopes