The Recall Desk
HighFDA (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.

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 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 In
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robot
Hazard
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 →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · mechanical failure

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