Class II — Sensus Healthcare, Inc.
| Recalling firm | Sensus Healthcare |
|---|---|
| Registered facility | SENSUS HEALTHCARE (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 23 units |
| Distribution | US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL. |
| Initiated | 2023-02-10 |
| Classified | 2023-03-08 |
| Terminated | 2024-01-31 |
| Recall number | Z-1235-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sensus Healthcare, Inc. (Z-1235-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91795/
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