Senhance Surgical System — Class I medical device recall Z-0170-2024
Terminated recall by Asensus Surgical Inc, reported 2023-11-08, distributed in FL, IL, LA, MN, NJ. Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System.
| Recall number | Z-0170-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asensus Surgical Inc, Durham, NC, United States |
| Recall initiated | 2023-09-15 |
| Classified | 2023-10-30 |
| Reported by FDA | 2023-11-08 |
| Terminated | 2024-09-26 |
| Distributed | FL, IL, LA, MN, NJ |
| Countries outside the US | DE, JP, LT |
| Quantity | 21 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00815440022075 |
| Serial numbers | 00006, 00007, 00008, 00011, 00012, 00016, 00017, 00018, 00019, 00024, 00025, 00028, 00029, 00031, 00035, 00036, 00038, 00040, 00041, 00042 |
| Model numbers | X9007696, X9007707, X9007708 |
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
Reason for recall
Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.
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-0170-2024. 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.