BEUDAMED
    FDA Recall Terminated

    daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.

    Recall: Z-1245-2007 · Initiated May 14, 2007

    Recall

    Recall Number
    Z-1245-2007
    Event Number
    38301
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2007
    Posted
    September 26, 2007
    Terminated
    December 3, 2007
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.

    Reason

    Product may malfunction and fail to start up on AC power.

    Action

    As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).

    Distribution

    Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.

    Quantity

    38 units