BEUDAMED
    FDA Recall Terminated

    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

    Recall: Z-0557-2019 · Initiated November 2, 2018

    Recall

    Recall Number
    Z-0557-2019
    Event Number
    81582
    FEI Number
    3006972752
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 2, 2018
    Terminated
    July 25, 2021
    Address
    Stephanix Zone Industrielle Du Bayon 10 rue Jean Moulin La Ricamarie France

    Description

    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

    Reason

    The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.

    Action

    The firm initiated the recall by email on 11/02/2018 to the sole US distributor. This email included a letter to be provided to the end user. The letter directed the user as follows: "As a precautionary measure and before your usual maintenance team intervention, the user should look at the equipment during all of its movement (as stated in the user manual). Immediately release the command if an abnormal movement is detected. If necessary, use the closest emergency switch to stop the system." f you need more information or technical assistance, you can phone your usual contact.

    Distribution

    US Nationwide Distribution in the states of FL, IN, WV, TN, MO, WI, CA, FL, GA, PA

    Quantity

    17 units