The Recall Desk
HighFDA (Devices)·Z-1302-2015·Announced 2015-04-01

Intuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault

Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal sensor failures and position 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 is classified as FDA Class II, and the hazard involves a mechanical/sensor fault in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Intuitive Surgical, Inc. is recalling 167 da Vinci Xi Surgical Systems (Model IS4000) worldwide. The recall involves specific Assy, Distal SUJ, Inner components with material numbers 380662-20 and 380662-21. The systems are distributed in the United States and 15 other countries, including Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.

The recall is due to a fault that causes distal SUJ (DSUJ) failures. This defect indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. The da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during various surgical procedures, including urologic, general laparoscopic, gynecologic, and thorascopic procedures.

Healthcare facilities and users should identify affected units by checking the material numbers and serial numbers listed in the recall documentation. Specific serial numbers are provided for both material number 380662-20 and 380662-21. Users should contact Intuitive Surgical for instructions on how to address the defect.

The recalled product

Product
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surg
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: 3680662-20: Serial numbers: 1311140273
  • 1311140370
  • 1311140385
  • 1311140148
  • 1311140099
  • 1311140152
  • 1311140081
  • 1311140473
  • 1311140561
  • 1311140409. Material number: 380662-21: Serial numbers: 1311140225
  • 1311140437
  • 1311140476
  • 1311140336
  • 1311140472
  • 1311140438
  • 1311140353
  • 1311140195
  • 1311140545
  • 1311140098 1311140189
  • 1311140465

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.

See all →

Same hazard · sensor failure

See all →