Asensus Surgical Inc recalls Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Su…

Recall date

September 15, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0170-2024

FDA classification

Class I

Brand / firm

Asensus Surgical Inc

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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