FDA recall Z-1262-2023

Intuitive Surgical, Inc. · Class II · device

Product

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

Reason for recall

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France

Key facts

Status: Ongoing
Initiation date: 2023-01-24
Report date: 2023-03-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2023