Device recall
Z-1235-2023: Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software…
FDA device recall · Class II · Sensus Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-1235-2023 |
|---|---|
| Recall event | 91795 |
| 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 |
| Product code | JAD |
| Recalling firm | Sensus Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2024 |
| 510(k) numbers | K150037 |
| FEI number | 3008513398 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database