da Vinci (and Ion)

Specs

notes

[{"label":"Verified (production anchor)","value":"Intuitive Surgical (NASDAQ: ISRG; founded 1995, Sunnyvale CA) is the dominant incumbent and the verified gold standard. VERIFIED installed base (SEC 10-Q, 3/31/2026): 11,395 da Vinci systems (+12% YoY), of which 1,464 are da Vinci 5; plus 1,041 Ion systems (+22% YoY). Q1 2026 procedures +17% worldwide; 431 da Vinci placed (232 of them da Vinci 5). da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Axis-extension framing","value":"Surgical robotics is physical AI operating in the MEDICAL regulatory regime. FDA clearance is the verified gating event for maturity. Intuitive clears it across multiple platforms + generations -> production."},{"label":"AI-substance: teleop baseline + shipped analytics AI; autonomy demo-only","value":"da Vinci is master-slave teleoperated. SHIPPED AI: Case Insights (AI analysis of system/kinematics/video for surgeon performance) and machine-vision interface features; Force Feedback is a shipped sensing feature (not autonomy). Autonomous suturing/tissue-lifting via VLMs (Johns Hopkins/Stanford) are RESEARCH demonstrations on da Vinci hardware, NOT shipped. 4,000-mile telesurgery is investigational/in-development."},{"label":"Claimed but NOT verified","value":"'43% less force' is a preclinical/marketing figure, not an outcomes-verified clinical result. The 1,464 da Vinci 5 subfigure is company-reported (corroborated, model-level breakout)."}]

products

da Vinci multi-port (X / Xi), da Vinci SP single-port, da Vinci 5 (5th-gen, FDA 510(k) Mar 14 2024, Force Feedback), and Ion endoluminal robotic bronchoscopy (FDA Feb 2019).

formFactor

surgical (teleoperated master-slave multi-port + single-port surgical robot; + endoluminal robotic bronchoscopy)

Manufacturer-attributed media (4)

Manufacturer-supplied media at the model level. Not tied to an independently verified named-site deployment. Verification posture is product-showcase from the maker, distinct from the deployment-verified evidence in the section above.

Components (2)

• da Vinci SureForm Stapleractuatorsafety-critical(primary safety)

  SureForm stapling instrument

  • mechanical wear · serious: FDA recall; lot removal and inspection of affected reloads.
  • other · catastrophic: FDA recall after a reload defect linked to a patient death; device correction.
• da Vinci Instrument Armactuatorsafety-critical(primary safety)

  Instrument arm

  • software fault · serious: FDA recall; software implementation-error correction.

Components carry componentClass + safetyCritical flag. ModelComponent rows carry safety_role (primary_safety / backup_safety / monitoring / non_safety) + optional supplier identity.

Regulatory filings (9)

• Z-1232-2026fda recall · us_fdarecalled

  Applicant: Intuitive Surgical

• Z-1262-2023fda recall · us_fdarecalled

  Applicant: Intuitive Surgical

• Z-0340-2023fda recall · us_fdarecalled

  Applicant: Intuitive Surgical

• Z-1855-2026fda recall · us_fdarecalled2026-03-11

  Applicant: Intuitive Surgical

• Z-1325-2025fda recall · us_fdarecalled2025-02-26

  Applicant: Intuitive Surgical

• K232610fda 510k · us_fdacleared2023-08-28

  Applicant: Intuitive Surgical

• fda_warning_letterfda warning letter · us_fdaclosed2013-07-16

  Applicant: Intuitive Surgical

• Z-1442-2013fda recall · us_fdarecalled2013-05-08

  Applicant: Intuitive Surgical

• K990144fda 510k · us_fdacleared1999-01-19

  Applicant: Intuitive Surgical

Incidents affecting da Vinci (and Ion) (10)

• da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)2026-03-11 · Recall
• da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use2026-02-02 · Recall
• Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)2026-01-28 · Recall
• da Vinci 5 console foot-pedal recall over a spring failure that can leave a pedal stuck pressed2025-02-26 · Recall
• Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)2024-09-04 · Recall
• da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component2023-02-23 · Recall
• da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments2022-10-07 · Recall
• Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)2020-12-02 · Recall
• FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events2013-07-19 · Regulatory action
• da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns2013-05-08 · Recall

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (5)

1. https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm ↗
2. https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm ↗
3. https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html ↗
4. https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/ ↗
5. https://www.fiercebiotech.com/medtech/intuitive-launches-latest-da-vinci-robot-force-feedback-controls ↗

Common questions

What is da Vinci (and Ion)?

Intuitive Surgical (NASDAQ: ISRG; founded 1995, Sunnyvale, California) is the dominant incumbent and verified gold standard of surgical robotics. Its da Vinci platform spans the multi-port X and Xi systems, the SP single-port system, and the fifth-generation da Vinci 5, which the FDA cleared via 510(k) on March 14, 2024 with a headline Force Feedback sensing feature, alongside the Ion endoluminal robotic bronchoscopy system cleared in February 2019. As of its SEC Form 10-Q for the quarter ended March 31, 2026, the verified installed base was 11,395 da Vinci systems, up 12 percent year over year and including 1,464 da Vinci 5 units, plus 1,041 Ion systems, up 22 percent, with worldwide procedures growing about 17 percent. Surgical robotics sits in the registry as a deliberate axis-extension: physical AI operating in the medical regulatory regime, where FDA clearance is the verified gating event for maturity, and Intuitive clears it across multiple platforms and generations, placing it at production maturity. On AI substance, da Vinci is a master-slave teleoperated system with shipped analytics-grade AI such as Case Insights and machine-vision interface features, and Force Feedback is a shipped sensing feature rather than autonomy; autonomous suturing and tissue manipulation via vision-language models are research demonstrations on da Vinci hardware, not shipped features, and the 4,000-mile telesurgery demonstration is investigational. The widely cited 43-percent-less-force figure is preclinical and marketing-sourced rather than an outcomes-verified clinical result.

Who makes da Vinci (and Ion)?

da Vinci (and Ion) is made by Intuitive Surgical, based in Sunnyvale, California, USA, founded in 1995.

Where is da Vinci (and Ion) deployed?

No verified deployments of da Vinci (and Ion) are currently on the DEPLOY registry. DEPLOY records deployments only when verified at a named site with a primary source; absence may reflect pre-deployment, research, or manufacturer-internal use.

What is da Vinci (and Ion)'s maturity stage?

da Vinci (and Ion) is at the production stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Production stage means high-volume manufacture and commercial-scale deployments are sustained.

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