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Health Canada Medical devices

Da Vinci X and Da Vinci XI Surigical Systems

Issued April 7, 2026
Issue
Product Da Vinci X and Da Vinci XI Surigical Systems Issue Medical devices - Performance What to do Customer notification. Arrange for visit by Intuitive technician to replace the defective screws in affected units. Audience Healthcare
Hazard description
Intuitive is initiating a voluntary correction involving the Universal Surgical Manipulator (USM) on the Da Vinci X and XI systems as certain USM's may contain screws located within the arm sub-assembly that may be susceptible to breaking.
Reference
ID
RA-82065