Recall Z-1191-2016— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2016-02-16, terminated 2016-09-21. It names 2 FDA 510(k) clearances: K131861, K081137. Product: 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..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-16
- Terminated
- 2016-09-21
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
- K081137 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.