FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
- Recall number
- Z-1429-2013
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
- Status
- Terminated
- Initiated
- 2011-09-19
- Posted
- 2013-05-29
- Terminated
- 2013-05-30
- Reason
- Clarification of existing labeling information and operating procedures.
- Root cause
- Labeling False and Misleading
- Action
- Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.
- Quantity
- NA
- Distribution
- Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
- Lot, serial or model codes
- Model number: 314850, versions 1-6
- 510(k) numbers
- ["K050369"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28