BEUDAMED
    FDA Recall Terminated

    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

    Recall: Z-2082-2016 · Initiated March 17, 2016

    Recall

    Recall Number
    Z-2082-2016
    Event Number
    74153
    Firm
    Medtronic Navigation, Inc.-Littleton
    FEI Number
    3004785967
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 17, 2016
    Terminated
    April 6, 2021
    Address
    300 Foster Street, Littleton, MA, 01460-2017

    Description

    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

    Reason

    It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

    Action

    Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.

    Distribution

    Nationwide Distribution

    Quantity

    US - 581