BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

    Recall: Z-2244-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2244-2012
    Event ID
    62571
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    July 11, 2012
    Classification Date
    August 22, 2012
    Termination Date
    June 6, 2016
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

    Reason

    A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.

    Code Info

    Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.

    Distribution

    Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.

    Quantity

    17 units