The Recall Desk
HighFDA (Devices)·Z-0419-2022·Announced 2022-01-05

da Vinci SP Surgical System Software Energy Delivery Defect

Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.

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 medical device recall involving potential energy delivery malfunction during surgical procedures. No illnesses or injuries have been reported in the source material, but the theoretical hazard of surgical energy delivery failure or inadvertent activation represents a risk-of-harm product category warranting close attention.

Plain-English summary

Intuitive Surgical, Inc. has recalled 46 da Vinci SP Surgical systems using software version OS4 v4.0.0 (P4_B327). Internal engineering evaluation identified a defect affecting the system's energy delivery mechanism.

The affected systems may experience either an inability to deliver surgical energy or inadvertent (unintended) delivery of energy during use. These malfunctions could require operating surgeons to intervene during the procedure and may cause troubleshooting delays.

The recalled systems have been distributed nationwide to Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.

The recalled product

Product
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robot / da Vinci System
Hazard
  • energy-delivery-failure
  • 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 (1)

  • All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category