Intuitive Surgical, Inc.: Device Recall

Recall #Z-0964-2026 · 08/21/2024

Class II: Risk

Recall Details

Recall Number: Z-0964-2026
Classification: Class II
Product Type: Device
Recalling Firm: Intuitive Surgical, Inc.
Status: Ongoing
Date Initiated: 08/21/2024
Location: Sunnyvale, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 144

Reason for Recall

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

Product Description

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

Distribution Pattern

US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.

Other Recalls by Intuitive Surgical, Inc.

Class II: Risk 12/15/2025

Access Port System tray may develop cracks potentially resulting in a sterility breach.
Class II: Risk 12/04/2025

Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Class II: Risk 11/07/2025

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
Class II: Risk 02/26/2025

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Class II: Risk 12/19/2024

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

View all recalls by Intuitive Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.