BEUDAMED
    FDA Recall Terminated

    American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.

    Recall: Z-1516-2013 · Initiated March 30, 2013

    Recall

    Recall Number
    Z-1516-2013
    Event Number
    65113
    Firm
    American Optisurgical Inc
    FEI Number
    1000135560
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2013
    Posted
    June 6, 2013
    Terminated
    March 24, 2014
    Address
    26902 Vista Ter, Lake Forest, CA, 92630-8123

    Description

    American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.

    Reason

    The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo

    Action

    "Urgent Medical Device Recall" notifications letters were sent to customers on May 20, 2013 via USPS registered mail. Included in the Recall Notification Letter were the recommended actions and instructions for customers. Questions were referred to (949) 580-1266.

    Distribution

    Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.

    Quantity

    194 units