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.
Reported: March 30, 2016 Initiated: February 16, 2016 #Z-1191-2016
Product Description
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 542 (351 SCC Touchpads and 191 PSC touchpads)
- Distribution
- 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, Taiwan, Turkey, United Kingdom and Venezuela.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product 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.. Recalled by Intuitive Surgical, Inc.. Units affected: 542 (351 SCC Touchpads and 191 PSC touchpads).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1191-2016.
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