Safety
Virtual Incision recalled software on 3 MIRA systems because a delay between the surgeon's hand controls and the robot arms could make motion on the screen stutter. The FDA rated it Class 2; the recall is completed.
A crash, recall, injury or investigation
What the source says
“to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.”
What it means
MIRA, from Virtual Incision, 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 MIRA
- Virtual Incision said MIRA is on sale in the US for colon surgery, and that it will announce later when the gynecology use goes on sale.
- The FDA cleared MIRA for benign (non-cancer) hysterectomy through the 510(k) route (K260817), and added needle-holding tools for stitching.
- HCA Florida Mercy Hospital did Florida's first hysterectomy with MIRA, as part of a US clinical study run under FDA rules.
- The FDA cleared MIRA through the De Novo route (DEN230025) for bowel surgery in adults, the first clearance of a robot this small.
- Virtual Incision said a version of MIRA would be tested aboard the International Space Station.