Asensus Surgical Inc: Medical Device Recall in 2023 - (Recall #: Z-0170-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: September 15, 2023

Date Posted: November 8, 2023

Recall Number: Z-0170-2024

Event ID: 93129

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.

Status: Terminated

Product Quantity: 21 units

Code Information:

UDI/DI 00815440022075, Serial Numbers: SN 00012, SN 00016, SN 00007, SN 00017, SN 00035, SN 00018, SN 00042, SN 00008, SN 00031, SN 00025, SN 00011, SN 00028, SN 00038, SN 00029, SN 00036, SN 00025, SN 00024, SN 00006, SN 00019, SN 00040, SN 00041, loaded with Software (SW) version 2.7.4

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated