Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 8, 2023
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 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 Laparo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Asensus Surgical Inc recalled Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Nu… - a critical-severity action.
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Nu… was recalled by Asensus Surgical Inc in November 8, 2023. Reason: Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System…. Check the official notice for the remedy. Verify recall #Z-0170-2024 with the FDA Devices before acting.
The recall
Asensus Surgical Inc issued this critical-severity FDA Devices recall-Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System….
- Critical
- severity level
- 21 units
- affected scope
- Class I
- classification
- November 8, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0170-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0170-2024) was formally reported on November 8, 2023, with the manufacturer initiating the action on September 15, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Asensus Surgical Inc is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 21 units.
The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0170-2024 |
| Date reported | November 8, 2023 |
| Date initiated | September 15, 2023 |
| Recalling firm | Asensus Surgical Inc |
| Firm location | Durham, NC |
| Affected scope | 21 units |
| Distribution | US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0170-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Asensus Surgical Inc. Units affected: 21 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Critical. Recall number: Z-0170-2024.
Where was the recalled product distributed? ▼
Distribution: US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0170-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 8, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.