FDA Recall Open, Classified

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

Recall: Z-0964-2026 · Initiated August 21, 2024

Recall

Recall Number
Z-0964-2026
Event Number
98048
Firm
Intuitive Surgical, Inc.
FEI Number
3001675293
Product Code
NAY
Status
Open, Classified
Root Cause
Device Design
Initiated
August 21, 2024
Posted
December 19, 2025
Address
1266 Kifer Rd, Sunnyvale, CA, 94086-5304

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

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 [email protected] 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 motor module sub-assembly. If you need further information or support concerning this notification, please contact the firm's Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]

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