FDA-Device2026-02-25Class IIPROCESSING DEFECT
Intuitive Surgical Da Vinci 5 console recalled for software display error
What this means
A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.
- If you operate a Da Vinci 5 console, verify your software version is P1.2.1
- Contact Intuitive Surgical for instructions on a software fix or rollback
- Do not perform surgery until the display issue is resolved
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-1428-2026More Intuitive Surgical recalls
- FDA-Device2026-07-22Intuitive Surgical da Vinci SP Instrument Arm Drape recalled for detachment risk
- FDA-Device2026-07-01Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk
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