The Recall Desk
HighFDA (Devices)·Z-2734-2015·Announced 2015-09-09

Intuitive Surgical Recalls da Vinci Xi Systems Due to Exposed Knife Blade

Intuitive Surgical is recalling 198 da Vinci Xi Surgical Systems because the Xi Stapler may have an exposed knife blade when used with P4 software.

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 surgical instrument with a potential exposed blade, which poses a risk of harm to patients or surgeons, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling 198 units of the da Vinci Xi Surgical System (Model IS4000) equipped with the Xi Stapler. The recall is due to complaints regarding a recoverable fault where the knife blade on the Xi Stapler may be exposed when the system is running P4 version software.

The affected devices were distributed worldwide, including in the United States, Italy, and Norway. The da Vinci Xi Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during various surgical procedures, including general, plastic, urologic, gynecologic, and thorascopic surgeries.

Hospitals and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, it should be removed from service and the manufacturer contacted for further instructions.

The recalled product

Product
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robot
Hazard
Affected units
198

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)

  • Model number IS4000

Distribution

Distributed nationwide across the United States.

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