BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0430-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0430-2021
    Event ID
    86555
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stereotaxis Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    November 18, 2020
    Initiation Date
    September 21, 2020
    Classification Date
    November 6, 2020
    Termination Date
    November 13, 2023
    Address
    4320 Forest Park Ave Ste 100, Saint Louis, MO, 63108-2979, United States

    Description

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

    Reason

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

    Code Info

    Devices with the following system numbers (serial): 105, 108, 113, 116, 124, 125, 126, 128, 130, 131, 134, 135, 138-142, 144, 147, 149, 154, 158, 162, 163, 169, 170, 172-174, 177-179, 181-183, 185, 187, 189, 190, 192-202, 205, 206, 208-210, 212, 214-222, 224-229, 231, 232, 235-242, 244, 245, 249, 251-256, 258-278, 280-284, 286, 287, 288, 290, and 297

    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