Drug recall
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray…
FDA recall event 91795 · Class II · Sensus Healthcare, Inc.
Key facts
| Event ID | 91795 |
|---|---|
| Recall numbers | Z-1235-2023 |
| Recalling firm | Sensus Healthcare, Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Feb 10, 2023 |
| Report date | Mar 15, 2023 |
| Termination date | Jan 31, 2024 |
| City | Boca Raton |
| State | FL |
| Country | United States |
| FEI number | 3008513398 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: