BEUDAMED
    FDA Enforcement Class II Terminated

    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

    Recall: Z-1235-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1235-2023
    Event ID
    91795
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sensus Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 15, 2023
    Initiation Date
    February 10, 2023
    Classification Date
    March 8, 2023
    Termination Date
    January 31, 2024
    Address
    851 Broken Sound Pkwy Nw Ste 215, Boca Raton, FL, 33487-3635, United States

    Description

    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

    Reason

    When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

    Code Info

    Software version 1.9.2 loaded onto Serial Numbers: 1512-2002; 1512-2003; 1606-2007; 1609-2010; 1609-2011; 1609-2018; 1612-2023; 1612-2025; 1705-2032; 1709-2046; 1803-2068; 1906-2137; 1909-2149; 1912-2167; 2003-2177; 2112-2201; 2112-2202; 2112-2208; 2112-2218; 2203-2232; 2203-2241; 2206-2264; 2206-2272

    Distribution

    US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.

    Quantity

    23 units