Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1960-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

da Vinci Xi Surgical System

Product Classification:

Class II

Date Initiated: November 21, 2018

Date Posted: May 20, 2020

Recall Number: Z-1960-2020

Event ID: 84023

Reason for Recall:

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Status: Terminated

Product Quantity: 74 USMs containing affected rotors.

Code Information:

Model: IS4000 UDI: 00886874114216 Device Listing: D215864 For System Name and USM Serial Numbers, refer to: ISIFA2018-15-C 806.10 Report_Affected Products List - Copy" files in Associated Documents.

Distribution Pattern:

U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated