Z-0139-2014Class II

Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer...

Name: Z-0139-2014 Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer...
Creator: Intuitive Surgical, Inc.
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 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).... FDA classified it as Class II and gives the reason as "Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0139-2014
Classification: Class II
Status: Terminated
Posted: 2013-11-04
Terminated: 2013-11-04
Recalling firm: Intuitive Surgical, Inc.
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive Surgical Inc sent an Product Notification to all affected customers via email on November 30, 2012. E-mail notifications advised users of an addendum to the User Manual for Covering the Patient Cart column that provided a recommended method for covering the da Vinci patient cart column to prevent splashing on the cart during a procedure. The addendum was attached to the e-mail and is available online. If you have any questions, please contact Customer Service at 1-800-876-1310. Outside the United States call +41 21 821 2020 or +800.0821.2020
Quantity in commerce: 1754 patient carts
Distribution: 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.
Product codes and lots: Model IS2000 and IS 3000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)