FDAHealthNovember 17, 2025

Intuitive Surgical, Inc. — Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

⚠️ 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.

Is this relevant to me?

Geography: US, LA, MA, NY, PA, TX, VA
Source agency: FDA
Category: Health
Published: November 17, 2025

US distribution: LA, MA, NY, PA, TX, and VA.

What's affected?

Product: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Brand: Intuitive Surgical, Inc.
Lot code: UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

Additional details

UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 12.

View original FDA notice →

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