Device product

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

Z-1428-2026

November 17, 2025

Class II

Product summary

Firm: Intuitive Surgical, Inc.
Event: Event 98200
Status: Ongoing
Classification: Class II
Quantity: 12
Official record key: device-enforcement:Z-1428-2026

Official wording

Reason: 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.

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

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

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

error event following the release of a software