BEUDAMED
    FDA Recall 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 · Initiated February 10, 2023

    Recall

    Recall Number
    Z-1235-2023
    Event Number
    91795
    Firm
    Sensus Healthcare, Inc.
    FEI Number
    3008513398
    Product Code
    JAD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 10, 2023
    Posted
    March 8, 2023
    Terminated
    January 31, 2024
    Address
    851 Broken Sound Pkwy Nw, Ste 215, Boca Raton, FL, 33487-3635

    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.

    Action

    Sensus healthcare issued an "Urgent Device Correction" to its consignees on 02/10/2023 by email. The notice requested the following actions: "Do not initiate beam delivery after a pause & resume sequence without verifying the amount of dose delivered. Do evaluate any patient treatments with version 1.9.2 that followed the pause & resume workflow. Do verify that the amount of dose to be delivered is as expected after each pause & resume sequence." The firm has developed a permanent software resolution for this issue. Customer service will contact the customer to coordinate upgrading to this revised software. Questions: Contact Sensus Customer Support at [email protected] or 561-578-4982

    Distribution

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

    Quantity

    23 units