Intuitive Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0088-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 17, 2011

Date Posted: November 6, 2013

Recall Number: Z-0088-2014

Event ID: 66434

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,090 consoles

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.

Voluntary or Mandated:

Voluntary: Firm initiated