Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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

FDA Recall Z-0170-2024 · Posted 2023-10-30

Recalling FirmAsensus Surgical Inc
Recall StatusTerminated
Product CodeNAY
Date Initiated2023-09-15
Date Terminated2024-09-26
Product Quantity21 units

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.

Firm Action

Asensus Surgical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 09/15/2023 by mail. The notice explained the problem, risk to health, and requested users to cease use of the device until software version 2.7.5 is installed.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑