The Recall Desk
HighFDA (Devices)·Z-1871-2014·Announced 2014-07-02

Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint

Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.

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 recall involves a medical device where a visual defect (orange-yellow tint) impairs the ability to differentiate tissue during surgery. This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness or injury.

Plain-English summary

Intuitive Surgical, Inc. is recalling 19 units of the IS4000 da Vinci Xi - Endoscope accessory, specifically the 0 Degree, 8mm Endoscope. The recall was initiated because, in some procedures, the use of the endoscope in conjunction with the IS4000 (da Vinci Xi) System results in a surgical view with an orange-yellow tint. This visual distortion can make it hard for surgeons to differentiate between tissue.

The affected units were distributed in the states of Florida, Texas, and New York. The specific product code associated with this recall is 470026-18. No specific dates or additional distribution details are provided in the source text.

Healthcare facilities and consumers who possess these specific endoscope accessories should stop using them and contact Intuitive Surgical, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Endoscope
Hazard
Affected units
19

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)

  • 470026-18

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

See all →

Same hazard · visual impairment

See all →