BEUDAMED
    FDA Recall Terminated

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    Recall: Z-2390-2015 · Initiated July 13, 2015

    Recall

    Recall Number
    Z-2390-2015
    Event Number
    71714
    Firm
    Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain
    FEI Number
    3002495042
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 13, 2015
    Posted
    August 14, 2015
    Terminated
    February 20, 2018

    Description

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    Reason

    Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient.

    Action

    FIELD CORRECTION NOTIFICATION letters dated July 13, 2015 were sent to all dealers. The letters instructed the dealers: to schedule the replacement of the current arrestor by a new design of resistive arrestor with a resistance of 1 M ohm between frame and floor (ground). Although the metallic arrestor is only implemented in the equipments manufactured from April 2013 till March 2015, the upgrade kit has to be implemented in all the installed base of Mobiles with the same configuration in order to ensure that even the arrestors installed as spare part are replaced. Sedecal will provide the necessary upgrade kits to all the customers or distributors. *** U.S. Distributor, Virtual Imaging (a Canon U.S.A. Company) will use letter entitled, FIELD CORRECTION NOTIFICATION, RADPRO 40kW - -DIGITAL MOBILE X-RAY SYSTEM and dated 7/13/2015 to communicate to end users. The letter states "Once Virtual Imaging receives the resistive arrestor, we will contact you to schedule the replacement on the Affected System that you service." Please contact Virtual Imaging, Inc.'s Technical Support for any questions at 561.893.8500 or [email protected]. ****

    Distribution

    Distributed US (nationwide) and in Canada.

    Quantity

    361 systems (U.S.); 5 systems (Foreign)