Agency classClass IIOur severity:High FDA (Devices)·Z-1304-2015·Announced 2015-04-01

Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 high-risk medical device (surgical robot) with a mechanical fault that could compromise safety, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling 167 da Vinci Xi Surgical Systems (Model IS4000) with material numbers 380647-20 and 380647-22. The recall is due to a fault that causes distal SUJ (DSUJ) failures, which indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.

The affected systems were distributed worldwide, including the United States (nationwide) and countries such as Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. The source text does not specify the number of reported injuries or illnesses associated with this defect.

Healthcare facilities should contact Intuitive Surgical, Inc. for instructions on how to address the defect. The source text does not provide specific consumer action steps beyond the recall notification.

The recalled product

Product: da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic…
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Robot
Hazard: mechanical-failure
sensor-mismatch
Affected units: 167

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 (20)

Material number: 380647-20
Serial numbers: 1311140430
1311140586
1311140058
1311140392. 1311140277
1311140307
1311140094
1311140100
1311140569
1311140102
1311140421
1311140092
1311140009
1311140070
1311140267
1311140333
1311140492
1311140391
1311140057
1311140294

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Intuitive Surgical, Inc.

See all →

Moderate
da Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
Severe
Da Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
High
Da Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
High
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
Severe
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13

Same hazard · mechanical failure