Senhance Robotic Surgical System uncontrolled arm motion malfunction
Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified FDA Class I, which requires a minimum Severe score per the rubric. No serious injuries or deaths have been reported, preventing a Critical rating.
Plain-English summary
Asensus Surgical Inc is recalling 21 units of the Senhance Surgical System robotic surgical platform (software version 2.7.4) distributed in New Jersey, Louisiana, Florida, Minnesota, Illinois, Germany, Japan, and Lithuania.
The recall addresses a malfunction in which the laparoscope instrument actuator arm rotates continuously in one direction after the surgeon disengages remote control. This malfunction has occurred and may recur on affected units.
The FDA classified this as a Class I recall due to potential patient safety risk from uncontrolled surgical instrument motion. Units with the listed serial numbers should not be used until repaired or replaced. Contact Asensus Surgical Inc for service.
The recalled product
- 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
- Manufacturer
- Asensus Surgical Inc
- Category
- Medical Device — Surgical Robot
- Hazard
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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 00024
- SN 00006
- SN 00019
- SN 00040
Distribution
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