PlainRecalls
FDA Devices Moderate Class II Terminated

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

Reported: June 5, 2013 Initiated: September 19, 2011 #Z-1429-2013

Product Description

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

Reason for Recall

Clarification of existing labeling information and operating procedures.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
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.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: NA.
Why was this product recalled?
Clarification of existing labeling information and operating procedures.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1429-2013.