BEUDAMED
    FDA Recall Terminated

    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

    Recall: Z-0460-2019 · Initiated November 2, 2018

    Recall

    Recall Number
    Z-0460-2019
    Event Number
    81444
    Firm
    Virtual Imaging, Inc.
    FEI Number
    1000649926
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 2, 2018
    Terminated
    August 19, 2020
    Address
    720 S Powerline Rd, Ste E, Deerfield Beach, FL, 33442-8156

    Description

    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

    Reason

    There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.

    Action

    The firm initiated the field correction by issuing a field safety notice on 11/03/2018. The letter identified the affected product, problem and action to be taken.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of, Canada, Italy

    Quantity

    253 units