BEUDAMED
    FDA Recall 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 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1340-2013
    Event Number
    64647
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    March 18, 2013
    Posted
    May 20, 2013
    Terminated
    November 6, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    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.

    Action

    The firm, ConMed, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/8/2013 to its customers after initial phone notifications. The letter identified the product, problem, and actions to be taken by the customers.

    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