Recall Z-2260-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-2260-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-01

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2019-04-01, terminated 2021-12-16. It names one FDA 510(k) clearance: K173906. Product: da Vinci SP surgical system. Reason: Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Terminated: 2021-12-16
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.·cleared 2018-05-31

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 SP surgical system

Reason for recall

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

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