Sensus Healthcare, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1235-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: February 10, 2023

Date Posted: March 15, 2023

Recall Number: Z-1235-2023

Event ID: 91795

Reason for Recall:

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.

Status: Terminated

Product Quantity: 23 units

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated