Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

Recalled April 5, 2023 · FDA recall Z-1293-2023 · Intuitive Surgical

Hazard

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications. · FDA Class II

Units

1,225 total USMs

Sold at

U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam

Description

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

Product

da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

Manufacturer(s)

Intuitive Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →