da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380...
FDA Device Recall #Z-0964-2026 — Class II — August 21, 2024
Recall Summary
| Recall Number | Z-0964-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 144 |
Product Description
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 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.
Lot / Code Information
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
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incisio... | Dec 15, 2025 |
| Z-1134-2026 | Class II | Brand Name: Ion Endoluminal System Product Nam... | Dec 4, 2025 |
| Z-1428-2026 | Class II | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/... | Nov 17, 2025 |
| Z-1232-2026 | Class II | Brand Name: Da Vinci Product Name: da Vinci X,... | Nov 7, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.