BEUDAMED
    FDA Recall Terminated

    VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin

    Recall: Z-1280-2012 · Initiated March 14, 2012

    Recall

    Recall Number
    Z-1280-2012
    Event Number
    61420
    Firm
    Christie Medical Holding Inc
    FEI Number
    3008161930
    Product Code
    KZA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 14, 2012
    Posted
    March 22, 2012
    Terminated
    October 23, 2012
    Address
    1256 Union Ave, Memphis, TN, 38104

    Description

    VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin

    Reason

    Instrument may tip over if not moved correctly.

    Action

    Christie Medical Holdings, Inc. sent an Urgent Medical Device Correction by letter on March 14, 2012 to all affected customers. The letter identified the product, problem and actions to be taken. The letter includes "Correct Transport" and "Do Not Pull labels to be applied to the unit. Customers were instructed to immediately examine their inventory, quarantine all product subject to correction and apply the labels prior to use. A Service Bulletin is enclosed that should be kept and placed with the User Guide for future reference and a Response Form to be completed and return as soon as possible. For questions contact Technical Service at 901-721-0300.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, China, Brazil, Czech Republic, Canada, Germany, Denmark, Spain, Great Britain, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Mexico, Malaysia, Netherlands, Norway, Philippines, Russian Federation, Saudi Arabia, Singapore, Thailand, Turkey, Taiwan, and United Arab Emirates

    Quantity

    450 units