The Recall Desk
HighFDA (Devices)·Z-2341-2018·Announced 2018-07-11

Intuitive Surgical Recalls da Vinci X Systems with Defective Arm Controller Boards

Intuitive Surgical is recalling 35 da Vinci X Surgical Systems because defective Arm Controller Joint boards have a high rate of failure.

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 high rate of failure in a critical surgical control component. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

Intuitive Surgical, Inc. is recalling specific da Vinci X Surgical Systems (Model IS4200) due to a defect in the Arm Controller Joint (ACJ) boards. The company identified that these boards were shipped with a defective component that results in a high rate of failure.

The recall affects 108 ACJ units installed on 35 surgical systems. These systems were distributed nationwide in the United States to facilities in Arizona, California, Florida, Georgia, Illinois, Iowa, Minnesota, Mississippi, Nebraska, Oklahoma, Tennessee, and Texas. Additionally, the affected units were distributed to Australia, Austria, Finland, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.

The da Vinci X Surgical System is intended to assist in the accurate control of endoscopic instruments during various surgical procedures, including urologic, general laparoscopic, gynecologic, and thoracoscopic surgeries. The system is used by trained physicians in an operating room environment. Specific serial numbers for the affected systems and ACJ boards are listed in the official recall documentation.

The recalled product

Product
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes,
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robotics
Hazard

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)

  • System S/N SL0008
  • ACJ S/N's P117154256
  • P117154263
  • P117154281
  • P117154286
  • System S/N SL0012
  • ACJ S/N's P117154260
  • P117154297
  • P117154298
  • P117154308
  • System S/N SL0013
  • ACJ S/N's P117154251
  • P117154255
  • P117154257
  • P117154305
  • System S/N SL0015
  • ACJ S/N's P117154274
  • P117154276
  • P117154289
  • P117154290

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

See all →

Same hazard · component failure

See all →