The Recall Desk
HighFDA (Devices)·Z-0133-2023·Announced 2022-11-02

da Vinci Surgical Robot Systems Risk of Unintended Energy Delivery

Intuitive Surgical's da Vinci X and Xi surgical systems can inadvertently deliver electrical energy to patients under specific instrument and pedal combinations, creating a risk during surgery.

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: This is an FDA Class II recall for a surgical system malfunction presenting a risk of unintended energy delivery to patients. No illnesses or injuries have been reported in the source text, placing this in the 'risk-of-harm product where injury has not yet been reported' category per the severity rubric.

Plain-English summary

Intuitive Surgical, Inc. is recalling 162 da Vinci X (IS4200) and Xi (IS4000) surgical systems running software version P10. The recall addresses a potential for inadvertent energy delivery from the surgical instruments under specific conditions involving instrument configuration and pedal activation.

The unintended energy delivery can occur when the following conditions are present: Force bipolar and bipolar instruments are both installed, Force bipolar is connected to the Force Triad generator while bipolar is not connected to a generator, the yellow pedal (Force bipolar) is pressed and released while the surgeon's head is positioned in the console, and then the blue pedal (bipolar) is pressed. This sequence can result in Force bipolar delivering energy when not intended.

These systems have been distributed to healthcare facilities across 26 U.S. states. Surgeons and facility staff should be aware of the specific configuration and control sequence that can trigger this malfunction. Users should contact Intuitive Surgical, Inc. for information on obtaining a software update or additional guidance on preventing this condition during surgical procedures.

The recalled product

Product
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robot Systems
Hazard
  • inadvertent-energy-delivery

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 (19)

  • Software version P10 (OS4 v10.0.0/A70_P10_B738) SOFTWARE
  • EMBEDDED RLS
  • IS4000 AND IS4200
  • A70_P10_B738 (Model: 610092-738) on Model Name/Model Number/UDI-DI: ASSY
  • PSCART
  • IS4000
  • 4-ARM
  • P10/380652-55/00886874110720
  • ASSY
  • SSC
  • P10/380677-28/00886874110744
  • VSS VISION SYSTEM
  • P10/381121-45/00886874110898
  • IS4200
  • P10/380620-47/00886874115404
  • VSC
  • RECONDITIONED
  • P10/380721-15/00886874115343
  • P10/380723-16/00886874115374

Distribution

Distributed in 27 states:

  • AK
  • AL
  • AZ
  • CA
  • CO
  • FL
  • GA
  • IA
  • IL
  • IN
  • KY
  • LA
  • MA
  • MD
  • MI
  • MO
  • MS
  • NC
  • NE
  • NV
  • OH
  • PA
  • SC
  • TN
  • TX
  • WA
  • WI

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