Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0088-2014

October 17, 2011

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 66434
Status
Terminated
Classification
Class II
Quantity
1,090 consoles
Official record key
device-enforcement:Z-0088-2014

Official wording

Reason: Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

Code information: model numbers 380610-04 through 38-610-14.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.