The Recall Desk
HighFDA (Devices)·Z-1428-2026·Announced 2026-02-25

Da Vinci 5 Surgical System Console Recalled Due to Software Error

Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The product is a surgical system where a loss of user interface content during surgery represents a high risk of harm, though no injuries were reported in the source text.

Plain-English summary

Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 (Model/Catalog Number: 380730) used for minimally invasive surgery.

A software error following the release of software version P1.2.1 can result in the loss of user interface content on an external monitor or tower monitor.

This recall affects 12 units distributed in LA, MA, NY, PA, TX, and VA. Users should follow manufacturer instructions regarding the software error.

The recalled product

Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Systems
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 6 states:

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