Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgica...
FDA Device Recall #Z-0139-2014 - Class II, December 11, 1930
Recall Summary
| Recall Number | Z-0139-2014 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 11, 1930 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 1754 patient carts |
Product Description
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.
Reason for Recall
Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
Distribution Pattern
Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.
Lot / Code Information
Model IS2000 and IS 3000
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2310-2026 | Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 ... | Apr 24, 2026 |
| Z-2521-2026 | Class II | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Apr 22, 2026 |
| Z-2046-2026 | Class II | Brand Name: Da Vinci X and Da Vinci Xi Product... | Apr 2, 2026 |
| Z-1855-2026 | Class I | Intuitive 8 mm SureForm 30 Gray Reloads Refer... | Mar 11, 2026 |
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.