BEUDAMED
    FDA Recall Terminated

    26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.

    Recall: Z-0196-2009 · Initiated September 22, 2008

    Recall

    Recall Number
    Z-0196-2009
    Event Number
    49549
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 22, 2008
    Posted
    October 24, 2008
    Terminated
    December 21, 2010
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.

    Reason

    Knob parts stick together, resulting in poor functionality of the knob.

    Action

    Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.

    Distribution

    Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and countries of Australia, Canada, China, England, France, Germany, Greece, Iberia, India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia, Singapore, South Africa, Switzerland, and Taiwan.

    Quantity

    2265 devices