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.
FDA Recall Z-1191-2016 · Posted None
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2016-02-16
Date Terminated2016-09-21
Product Quantity542 (351 SCC Touchpads and 191 PSC touchpads)
Firm Action
Urgent Medical Device Recall letters were sent on March 2, 2016. Letters advised users of the issue and that Intuitive Representative will visit each site to replace the affected compact flash card.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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