Model note · Surgical Robot
Intuitive da Vinci Xi Surgical System
The da Vinci Xi (model IS4000) is Intuitive's fourth-generation multiport robotic surgery system, used for urologic, general, gynaecologic and thoracic minimally invasive procedures. A surgeon at a separate console drives wristed instruments and a 3D HD endoscope mounted on four boom-mounted arms. Its distinctive features are the overhead boom, an endoscope that can move to any arm, and table motion that is integrated with the robot.
The model
Maker, model and type.
- Maker
- Intuitive Surgical, Inc.
- Model
- da Vinci Xi Surgical System (IS4000)
- Device type
- Surgical Robot
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Main subsystems | Surgeon Console, Patient Side Cart and Vision Side Cart, used with an endoscope, EndoWrist instruments and accessories | Source |
| Number of instrument arms | 4, and the endoscope can be fitted to any of the four | Source |
| Arm architecture | Boom-mounted arms with multi-position set-up joints | Source |
| Vision | 3D HD stereo viewer with built-in Firefly fluorescence imaging | Source |
| Integrated energy | ERBE VIO dV generator, with presets switched from the surgeon console | Source |
| Stapler reload lengths | 30, 45 and 60 mm | Source |
| FDA clearance | 510(k) K131861, decision date 28 March 2014, product code NAY, regulation 876.1500 | Source |
| Regulatory class (US) | Class II | Source |
| Patient population | Adult and paediatric use, by trained physicians in an operating room | Source |
Recalls
Known FDA recalls.
- Z-2046-20262026-04-02
Cannula mount screws on some manipulators may break over time; if all six fail the mount can separate.
FDA record - Z-1232-20262025-11-07
Software error let arms that failed the insertion ballscrew diagnostic test stay in clinical use.
FDA record - Z-1293-20232023-02-10
USM instrument carriage could be loose because the linear rail was out of specification.
FDA record - Z-1262-20232023-01-24
Arms identified from PM data as at risk of insertion ballscrew failure and uncontrolled carriage movement.
FDA record - Z-0925-20202019-07-26
Possibly defective capacitors on cart boards causing vision loss or non-recoverable errors 307 or 319.
FDA record - Z-1960-20202018-11-21
Arm manufacturing variation causing persistent recoverable fault 23087 and loss of arm function.
FDA record - Z-1896-20202019-04-11
High friction points in manipulators causing resistance, hesitation and jerking of arm movement.
FDA record
Safety
Safety warnings from the record.
- A failed insertion ballscrew can let the instrument carriage move without command along the insertion axis, which may injure tissue. Source
- Separation of the cannula mount from the arm is possible on affected arms, so the mount should be checked before each procedure. Source
- Earlier P5 software had an anomaly that could cause unexpected master and instrument tip movement, which shows why the system software must be kept at the level Intuitive specifies. Source
Sources
Where this note comes from.
- Intuitive, da Vinci Xi product page
- Intuitive, da Vinci Xi system brochure (PDF)
- FDA 510(k) database entry K131861
- FDA 510(k) summary K240852 (IS4000 and IS4200)
- openFDA recall search, da Vinci Xi
- openFDA MAUDE problem counts, da Vinci Xi
Not covered: The IS4000 user and service manuals are only on Intuitive's customer portal, so the full fault code list, electrical ratings, dimensions and weights could not be sourced; the only error codes given are the three named in FDA recall notices.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Surgical Robot