FDA recall Z-1961-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-11-21

Report date

2020-05-20

Termination date

2022-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2020