Patient Cart used in conjunction with the da Vinci S surgical and SI… — Class II medical device recall Z-0139-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-11-13, distributed in PR. Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems
| Recall number | Z-0139-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 1930-12-11 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2013-11-04 |
| Distributed | PR |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, JP, KR, KW, MX, NL, NO, PA, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE |
| Quantity | 1,754 patient |
| Model numbers | 3000, IS2000 |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.