FDA Enforcement Class II Ongoing

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

Recall: Z-0964-2026 · Reported December 31, 2025

Enforcement

Recall Number
Z-0964-2026
Event ID
98048
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Intuitive Surgical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
December 31, 2025
Initiation Date
August 21, 2024
Classification Date
December 19, 2025
Address
1266 Kifer Rd, N/A, Sunnyvale, CA, 94086-5304, United States

Description

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

Reason

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

Code Info

UDI-DI: 00886874119747. Serial Numbers: 10476314, 10485693, 10496049, 10497992, 10503432, 10503433, 10507302, 10509551, 10511044, 10511047, 10516467, 10518960, 10518961, 10522438, 10522439, 10522441, 10523771, 10523773, 10523775, 10523776, 10523777, 10523778, 10523779, 10523780, 10523781, 10529917, 10529918, 10529919, 10529920, 10529922, 10534426, 10534428, 10534429, 10534430, 10534752, 10534753, 10534754, 10534755, 10534757, 10543027, 10543028, 10543048, 10543051, 10544670, 10544676, 10544677, 10544678, 10547713, 10547717, 10547724, 10547728, 10551553, 10551554, 10552616, 10552618, 10552620, 10552621, 10556681, 10556682, 10558195, 10558197, 10558198, 10558202, 10560603, 10560604, 10560607, 10562584, 10562585, 10562586, 10562588, 10565609, 10565610, 10565614, 10567141, 10567143, 10567145, 10569365, 10569367, 10569368, 10569369, 10570704, 10570705, 10570706, 10570707, 10573677, 10573678, 10573679, 10573680, 10573681, 10573682, 10573683, 10573684, 10573685, 10573686, 10576019, 10576021, 10576022, 10576023, 10576024, 10576025, 10576026, 10576027, 10576028, 10579442, 10579446, 10579453, 10579455, 10579456, 10579457, 10579461, 10579466, 10582427, 10582428, 10582429, 10591177, 10591179, 10591180, 10591184, 10591197, 10594614, 10594615, 10594616, 10594617, 10594618, 10594619, 10597107, 10597108, 10597109, 10597110, 10599042, 10599044, 10599045, 10599048, 10600750, 10600753, 10603334, 10603335, 10603343, 10603344, 10603345, 10603367, 10605468, 10606129, 10606133

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.

Quantity

144