FDA recall, , Moderate risk
Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display
The da Vinci 5 Surgeon Console Viewer Display has outdated firmware that may cause loss of 3D or complete visualization, potentially leading to injury.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc. of Sunnyvale, California recalled the da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, because the Viewer Display has outdated firmware that may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.
The recall began December 30, 2025, and was added to the FDA's Enforcement Report on February 12, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and part code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
da Vinci 5 Surgeon Console Viewer Display, Assy, DV5 Console, IS5000
- UDI-DI
- 00886874119747
- Part code
- 380730-45
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Kansas, Arizona, Massachusetts, Florida, Michigan, North Carolina, Illinois, District of Columbia, Texas, Kentucky, Mississippi, California, Minnesota, Nevada, New York, Wisconsin, Idaho, Georgia, Connecticut, South Carolina, Utah, Virginia.
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98205
- Recall number
- Z-1355-2026
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
