Safety
Intuitive started a Class 2 recall covering da Vinci X, Xi and da Vinci 5. A software error let instrument arms that failed a safety self-test stay in use.
A crash, recall, injury or investigation
What the source says
“Due to a software implementation error that allowed instruments arms failing an important diagnostic test”
What it means
da Vinci 5, from Intuitive, 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: A surgeon in the operating room controls it; it doesn't operate on its own.
More on da Vinci 5
- Intuitive said it placed 315 da Vinci 5 systems in the third quarter of 2026, up from 240 a year earlier.
- Intuitive placed 246 da Vinci 5 systems with hospitals in the second quarter of 2026, up from 180 a year earlier.
- The FDA cleared da Vinci 5 for certain heart operations, such as mitral valve repair, done through small cuts between the ribs.
- da Vinci 5 received the CE mark, which allows it to be sold in Europe, for adults and children.
- Intuitive began its full commercial rollout of da Vinci 5 in the US in 2025.
- Intuitive said da Vinci 5 would first go to a small number of US customers before a wider launch.