Recall Z-0964-2026— Intuitive Surgical, Inc.

Name: FDA recall Z-0964-2026
Creator: U.S. Food and Drug Administration
Published: 2024-08-21

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-08-21. It names one FDA 510(k) clearance: K232610. Product: 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.

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-21
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc.·cleared 2024-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.