Home / Recalls / Intuitive Surgical, Inc. / Z-1961-2020

Z-1961-2020 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
November 21, 2018
Termination Date
May 31, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
74 USMs containing affected rotors

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.

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.

Code Information

Model: IS4200 UDI: 00886874114216 Device Listing: D295931

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