Recall Z-0964-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
| Date | Dec 19, 2025 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | On 8/21/2024, correction notices were sent to customers who were informed of the following: 1) Share this notification with all personnel at your site who perform and support da Vinci procedures. 2) Inform affected personnel when the correction has been completed. 3) Complete and return the acknowledgement form via email to Recalls@intusurg.com 4) Retain a copy of this letter and the acknowledgement form for your files. 5) Firm is actively working on making updated motor module assemblies available. Once available, an Intuitive representative will schedule a visit to replace the affected moto |
| Quantity | 144 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation Intuitive Surgical, Inc., Mar 14, 2024 |