Z-0170-2024 Class I Terminated
FDA device recall Z-0170-2024 was initiated by Asensus Surgical Inc on September 15, 2023 and is designated Class I. 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 Actu… The recall status is terminated (terminated September 26, 2024). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- September 15, 2023
- Termination Date
- September 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
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.
Distribution Pattern
US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
Code Information
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