FDA recall Z-1428-2026

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-11-17

Report date

2026-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2026