FDA recall Z-1293-2023

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-02-10

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2023