PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: November 8, 2023 Initiated: September 15, 2023 #Z-0170-2024

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

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.

Details

Recalling Firm
Asensus Surgical Inc
Units Affected
21 units
Distribution
US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
Location
Durham, NC

Frequently Asked Questions

What product 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. Recalled by Asensus Surgical Inc. Units affected: 21 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Critical. Recall number: Z-0170-2024.

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