Sensus Healthcare Inc — Class II medical device recall Z-1235-2023
Terminated recall by Sensus Healthcare, Inc., reported 2023-03-15, distributed in FL, IA, IL, IN, NC, NM, NY. When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unex
| Recall number | Z-1235-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sensus Healthcare, Inc., Boca Raton, FL, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-03-08 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2024-01-31 |
| Distributed | FL, IA, IL, IN, NC, NM, NY |
| Quantity | 23 units |
| 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 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1235-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.