BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1293-2023 · Initiated February 10, 2023

    Recall

    Recall Number
    Z-1293-2023
    Event Number
    91503
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    February 10, 2023
    Posted
    March 28, 2023
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    Description

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

    Reason

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

    Action

    On 02/10-13/2023, Intuitive Surgical sent "Urgent Medical Device Correction" letters via email to inform two Groups of Customer (Group 1 and Group 2) that, a population of da Vinci Z and Xi Systems instrument arms (USMs-Universal Surgical Manipulators) have instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail. This condition may also lead to increased friction along the insertion axis. Instructions for Customers in Group 1 (reference Appendix A of their Letter): Stop/Cease use of the affected systems until Intuitive Representatives can replace the affected USMs on their systems. Instructions for Customers in Group 2 (reference Appendix B of their Letter): Can continue to use affected systems, but prior to each use, need to perform inspection of all the instrument carriages using the "Instrument Carriage Inspection Instructions" (refer letter for details of inspection). For questions or additional guidance: -US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. -Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] -South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or [email protected] -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or [email protected] -Taiwan: 886-2-2-27008181 (9 AM to 6:00 PM CST) or [email protected] -India: 1800 103 6952 (9:00 AM to 6:00 PM IST) or Email address: [email protected]

    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

    Quantity

    1,225 total USMs