BEUDAMED
    FDA Recall Terminated

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Recall: Z-0152-2008 · Initiated October 4, 2007

    Recall

    Recall Number
    Z-0152-2008
    Event Number
    45518
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 4, 2007
    Posted
    February 22, 2008
    Terminated
    March 31, 2011
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Reason

    Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that

    Action

    A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections.

    Distribution

    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom.

    Quantity

    63 total units