SRT-100 Vision (Sensus) – Unexpected Dose Delivery (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Sensus Healthcare, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Sensus Healthcare, Inc. is recalling Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superfi due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 support@sensushealthcare.com or 561-578-4982
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, IN, IA, NM, NY, NC
Page updated: Jan 10, 2026