BEUDAMED
    FDA Recall Terminated

    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

    Recall: Z-0973-2014 · Initiated July 25, 2013

    Recall

    Recall Number
    Z-0973-2014
    Event Number
    67363
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    3004785967
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 25, 2013
    Posted
    February 28, 2014
    Terminated
    April 17, 2019
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

    Reason

    Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)

    Action

    Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.

    Distribution

    USA (nationwide) Distribution

    Quantity

    449 in US