BEUDAMED
    FDA Recall Terminated

    Niobe ES System, Models 001-006000-1 and 001-006100-1

    Recall: Z-0430-2021 · Initiated September 21, 2020

    Recall

    Recall Number
    Z-0430-2021
    Event Number
    86555
    Firm
    Stereotaxis Inc
    FEI Number
    3003084417
    Product Code
    PJB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 21, 2020
    Terminated
    November 13, 2023
    Address
    4320 Forest Park Ave, Ste 100, Saint Louis, MO, 63108-2979

    Description

    Niobe ES System, Models 001-006000-1 and 001-006100-1

    Reason

    There is a potential for fire in the inside computer cabinet.

    Action

    The firm will be contacting consignees via email and providing an electronic Urgent Field Safety Notice and Customer Reply Form. Consignees are asked for return the acknowledgement form to the firm within 30 days of receipt.

    Distribution

    US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan

    Quantity

    121