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.
FDA Recall Z-0088-2014 · Posted 2013-10-28
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2011-10-17
Date Terminated2013-10-28
Product Quantity1,090 consoles
Reason for Recall
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Firm Action
Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital.
Root Cause
Use error
Distribution Pattern
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.
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.