FDA Device recall Z-1235-2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2
- FDA Device
- Class II
- terminated
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2 by Sensus Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1235-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-10 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sensus Healthcare |
| Distribution | FL, IA, IL, IN, NC, NM, NY |
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
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.
Identifiers
| code_info | Software version 1.9.2 loaded onto Serial Numbers: 1512-2002; 1512-2003; 1606-2007; 1609-2010; 1609-2011; 1609-2018; 16…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2023%22
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