Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invas...
FDA Recall #Z-1428-2026 — Class II — November 17, 2025
Product Description
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Reason for Recall
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.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
Code Information
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated