Recall Z-1961-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-1961-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-21

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-11-21, terminated 2022-05-31. It names one FDA 510(k) clearance: K171294. Product: da Vinci X Surgical System. Reason: 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..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-21
Terminated: 2022-05-31
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K171294 — da Vinci X Surgical SystemIntuitive Surgical, Inc.·cleared 2017-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

da Vinci X Surgical System

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.