Recall Z-0170-2024
Asensus Surgical Inc · initiated September 15, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
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
Codes / lots: 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
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0170-2024
- Initiated
- September 15, 2023
- Posted by FDA
- October 30, 2023
- Terminated
- September 26, 2024
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 21 units
- Distribution
- US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
- Recalling firm
- Asensus Surgical Inc, Durham, NC