FDA recall Z-0964-2026

Intuitive Surgical, Inc. · Class II · device

Product

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

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-08-21
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0964-2026