BEUDAMED
    FDA Enforcement Class II Terminated

    Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

    Recall: Z-1340-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1340-2013
    Event ID
    64647
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 29, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    May 20, 2013
    Termination Date
    November 6, 2013
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    Description

    Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

    Reason

    The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.

    Code Info

    VP1600

    Distribution

    Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.

    Quantity

    267 units