FDA Devices recall · Reported November 13, 2013
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 t
Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
Intuitive Surgical, Inc. recalled Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive… - a moderate-severity action.
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive… was recalled by Intuitive Surgical, Inc. in November 13, 2013. Reason: Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI system…. Check the official notice for the remedy. Verify recall #Z-0139-2014 with the FDA Devices before acting.
The recall
Intuitive Surgical, Inc. issued this moderate-severity FDA Devices recall-Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI system….
- Moderate
- severity level
- Class II
- classification
- November 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0139-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0139-2014 |
| Date reported | November 13, 2013 |
| Date initiated | December 11, 1930 |
| Recalling firm | Intuitive Surgical, Inc. |
| Firm location | Sunnyvale, CA |
| Affected scope | 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, Ir… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0139-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026