FDA-Device2023-03-22Class II
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
Intuitive Surgical, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
Affected count
9
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2023Don't want to check this manually?
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