Intuitive Surgical da Vinci 5 Surgeon Console display recalled for firmware defect causing vision loss
What this means
Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.
- If your facility operates a da Vinci 5 with the affected serial numbers (SQ0326–SQ0470 range), contact Intuitive Surgical immediately
- Do not use the affected console for surgery until the firmware is updated
- Have Intuitive Surgical perform a firmware update on your display assembly
The agency's original wording
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2026More Intuitive Surgical recalls
- FDA-Device2026-07-22Intuitive Surgical da Vinci SP Instrument Arm Drape recalled for detachment risk
- FDA-Device2026-07-01Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.