da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Reported: November 6, 2013 Initiated: October 17, 2011 #Z-0088-2014
Product Description
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Reason for Recall
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1,090 consoles
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: 1,090 consoles.
Why was this product recalled? ▼
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0088-2014.
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