FDA Device recall Z-1428-2026
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery by Intuitive Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1428-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-17 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Intuitive Surgical |
| Distribution | LA, MA, NY, PA, TX, VA |
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Reason
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.
Identifiers
| code_info | UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2026%22
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