The Recall Desk
HighFDA (Devices)·Z-1870-2014·Announced 2014-07-02

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

Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 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 is classified as FDA Class II. The hazard involves a visual defect that could impair surgical decision-making (differentiating tissue), representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Intuitive Surgical, Inc. is recalling 20 units of the IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. The recall is due to a visual defect where the surgical view has an orange-yellow tint during some procedures. This tint can make it hard for surgeons to differentiate between tissue.

The affected endoscope accessories were distributed in the states of Florida, Texas, and New York. The specific product code for the recalled units is 470027-20.

Healthcare providers should stop using the affected endoscope accessories and contact Intuitive Surgical for further instructions. Consumers are not expected to have these products in their homes, as they are surgical instruments used in medical facilities.

The recalled product

Product
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Endoscope
Hazard
Affected units
20

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)

  • 470027-20

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.

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