Device recall
Z-0170-2024: Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration (…
FDA device recall · Class I · Asensus Surgical Inc
Key facts
| Recall number (Z-number) | Z-0170-2024 |
|---|---|
| Recall event | 93129 |
| Product | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system |
| Product code | NAY |
| Recalling firm | Asensus Surgical Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 26, 2024 |
| 510(k) numbers | K223095 |
| FEI number | 3007593944 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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