Intuitive Surgical, Inc.: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Intuitive Surgical, Inc.
- Product
- Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution: LA, MA, NY, PA, TX, and VA.
- Recall initiated
- 2025-11-17
- Code info
- UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
- Product quantity
- 12
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Sunnyvale
- State
- CA
- Country
- United States
- Event id
- 98200
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