Reported Nov 8, 2023 · Terminated
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent…
Asensus Surgical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Asensus Surgical Inc · 1 Tw Alexander Dr Ste 160 · Durham, NC · 27709
Is this the product you have?
- Senhance Surgical System
- which includesManipulator 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
- Lot codes and dates
- UDI/DI 00815440022075
- Serial Numbers
SN 00012SN 00016SN 00007SN 00017SN 00035SN 00018SN 00042SN 00008SN 00031SN 00025SN 00011SN 00028SN 00038SN 00029SN 00036SN 00025SN 00024SN 00006SN 00019SN 00040SN 00041loaded with Software (SW) version 2.7.4
- Amount recalled
- 21 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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