Z-0170-2024Class I

Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708)...

Name: Z-0170-2024 Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708)...
Creator: Asensus Surgical Inc
Published: 2023-09-15
License: https://open.fda.gov/license/

Asensus Surgical, Inc. / initiated 2023-09-15 / Terminated / root cause: software

FDA source

Asensus Surgical Inc began a recall of Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696)... on 2023-09-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0170-2024
Classification: Class I
Status: Terminated
Initiated: 2023-09-15
Posted: 2023-10-30
Terminated: 2024-09-26
Recalling firm: Asensus Surgical, Inc.
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
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 21 units
Distribution: US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2024	Class I	Terminated	Voluntary: Firm initiated	2023-11-08	2023-10-30

Product code NAY

K223095Class IISenhance Surgical SystemAsensus Surgical, Inc. / cleared 2023-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)