FDA-Device2026-02-25Class II
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Intuitive Surgical, Inc.
Hazard
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Sold states
US distribution: LA, MA, NY, PA, TX, and VA.
Affected count
12
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2026Original summary
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1 Distribution: US distribution: LA, MA, NY, PA, TX, and VA. Affected quantity: 12
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