Intuitive Surgical, Inc. recalls da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to a…
- Recall date
- February 16, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1191-2016
- FDA classification
- Class II
- Brand / firm
- Intuitive Surgical, Inc.
- Sold / distributed
- US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiw…
What was recalled
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
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