Intuitive Surgical Da Vinci 5 console recalled for software display error
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.
From the FDA notice · Read the official notice ↗ · All Intuitive Surgical recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
- Sold in
- US distribution: LA, MA, NY, PA, TX, and VA.
- Made for
- All ages (0 months and older)
Details
- Units affected
- 12
- Illnesses reported
- None reported
- Manufactured in
- 1266 Kifer Rd, Sunnyvale, CA, United States
- Classification
- Class II
- Recall number
- Z-1428-2026
In the FDA's words
- Description
- 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
- 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.