FDA DeviceClass IINotable

FDA Recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software

Date: 2026-06-10
Brand: Intuitive Surgical, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Hazard

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Remedy

1357 systems

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