Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyval
FDA device recall Z-0139-2014 · posted 2013-11-04 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 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,
- Date initiated
- 0012-11-30
- Date posted
- 2013-11-04
- Date terminated
- 2013-11-04
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |