Asensus Surgical Inc Recall 93129
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
Asensus Surgical Inc Recall 93129 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0170-2024 |
| Event ID | 93129 |
| Event 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 |
| Product Type | Devices |
| Distribution | Us Nationwide - Worldwide Distribution NJ, LA, FL, MN, IL, Germany, Japan, Lithuania |
| Quantity | 21 units |
| Recall 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. |
| Device Classification | 20231108 |
| Device Code Info | 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 |
| Center Classification Date | 20231030 |
| Recall Initiation Date | 20230915 |
| Recalling Firm | Asensus Surgical Inc |
| Initial Notification | Letter |
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