Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur
FDA device recall Z-0170-2024 · posted 2023-10-30 · Terminated
Recall details
- Recalling firm
- Asensus Surgical Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 21 units
- Distribution
- US: NJ, LA, FL, MN, IL, and Germany, Japan, Lithuania
- Date initiated
- 2023-09-15
- Date posted
- 2023-10-30
- Date terminated
- 2024-09-26
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Senhance Surgical System (K223095) | Asensus Surgical, Inc. | 2023-03-16 |