Recall Z-0170-2024 ยท NAY System, Surgical, Computer Controlled Instrument
Asensus Surgical Inc
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
| Date | Oct 30, 2023 (initiated Sep 15, 2023) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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. |
| Quantity | 21 units |
| Distribution | US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223095 | Senhance Surgical System Asensus Surgical, Inc., Mar 16, 2023 |