FDA DevicesClass II
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used fo...
Published: February 25, 2026Recall ID: Z-1428-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Affected Products
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98200 |
| Address 1 | 1266 Kifer Rd |
| Code info | UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1 |
| Postal code | 94086-5304 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 12 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251117 |
| Initial firm notification | Letter |
| Center classification date | 20260218 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution: LA, MA, NY, PA, TX, and VA.