# FDA recall Z-0170-2024

> **Asensus Surgical Inc** · Class I · device recall initiated 2023-09-15.

## 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.

## Distribution

US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania

## Key facts

- **Recall number:** Z-0170-2024
- **Recalling firm:** Asensus Surgical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2023-09-15
- **Report date:** 2023-11-08
- **Termination date:** 2024-09-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0170-2024

## Citation

> AI Analytics. FDA recall Z-0170-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0170-2024. Source: US FDA. Licensed CC0.

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