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U.S. Department of Health and Human Services

Class 1 Device Recall Asensus

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 Class 1 Device Recall Asensussee related information
Date Initiated by FirmSeptember 15, 2023
Date PostedOctober 30, 2023
Recall Status1 Completed
Recall NumberZ-0170-2024
Recall Event ID 93129
510(K)NumberK223095 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
ProductSenhance 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
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
Recalling Firm/
Manufacturer		 Asensus Surgical Inc
1 Tw Alexander Dr Ste 160
Durham NC 27709
For Additional Information ContactRavi Kommineni
763-227-5896 Ext. 140
Manufacturer 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 2		Nonconforming Material/Component
ActionAsensus 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 in Commerce21 units
DistributionUs Nationwide - Worldwide Distribution NJ, LA, FL, MN, IL, Germany, Japan, Lithuania
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = NAY
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