Recall Z-1355-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
| Date | Feb 12, 2026 (initiated Dec 30, 2025) |
| Status | Open, Classified |
| Reason | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality. |
| Root cause | Process change control |
| Action | On 12/30/2025, correction notices were mailed and emailed to customers who were informed the following: If single-viewer failure occurs during a procedure, when clinically safe to do so, restart the system to restore 3D visualization in the viewer. If dual-viewer failure occurs during a procedure, be aware that instrument motion will not be automatically halted by the system. Instrument motion can be halted by removing the surgeon s head from the viewer. The surgeon maintains the ability to control the instruments while their head is in the viewer. To ensure instruments do not cause unintend |
| Quantity | 47 |
| Distribution | US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation Intuitive Surgical, Inc., Mar 14, 2024 |