FDA-Device2026-02-25Class IIPROCESSING DEFECT
Intuitive Surgical Da Vinci 5 console recalled for software display error
Check your Da Vinci 5 console software version
A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.
- If you operate a Da Vinci 5 console, verify your software version is P1.2.1
- Contact Intuitive Surgical for instructions on a software fix or rollback
- Do not perform surgery until the display issue is resolved
Hazard
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Sold states
US distribution: LA, MA, NY, PA, TX, and VA.
Affected count
12
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2026More Intuitive Surgical, Inc. recalls
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Cautery Hook instruments recalled for frayed or broken cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Mega Needle Driver recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Grasping Retractor recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S and Si Monopolar Curved Scissors recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S, Si Double Fenestrated Grasper recalled for broken grip cables
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