Safety
FDA Class I recall: malfunctions could cause unintended robot movement. Five US devices affected; no patient harm reported.
A crash, recall, injury or investigation
What the source says
“There has been no patient impact or harm that has occurred due to this issue”
What it means
Senhance Surgical System, from Asensus Surgical (formerly TransEnterix), owned by Karl Storz, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: Our sources report it working without human help.
More on Senhance Surgical System
- Karl Storz said it would start an orderly end of service for Senhance, stop work on the LUNA robot and retire the Asensus brand.
- A North Carolina layoff notice showed about 108 Asensus jobs being cut, with the layoffs taking effect on 1 March 2027.
- German endoscope maker Karl Storz completed its purchase of Asensus for 35 cents a share in cash.
- Asensus recalled Senhance because faults could make the robot move on its own. The FDA called it a Class I recall, the most serious kind. Five US devices were affected and no patient harm was reported.
- Asensus showed LUNA, a planned next surgical system. It was still in development and had not been sent to the FDA.
- The FDA cleared the Senhance robot through the 510(k) route. It already had a CE mark for sale in Europe.