Lower riskMedical device recall · FDA · Published November 17, 2025
Da Vinci 5 Surgical System Software Error May Cause Monitor Content Loss
Intuitive Surgical recalls Da Vinci 5 surgical systems with model 380730 that may lose monitor content due to a software error. Affected units have specific UDI-DI and software version.
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.
Take action
Contact the company
📍Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd · Sunnyvale, CA 94086-5304
“Da Vinci 5 Surgical System Software Error May Cause Monitor Content Loss.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50648-da-vinci-5-surgical-system-software-error-may-cause-monitor. Based on FDA recall #Z-1428-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2026%22&limit=1).
The FDA announced on November 17, 2025, that Intuitive Surgical, Inc. is recalling Da Vinci 5 ASSY and DV5 CONSOLE surgical systems due to a software error that can cause loss of user interface content on monitors. The agency issued recall number Z-1428-2026 for the voluntary Class II recall.
How to tell if you have it
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730
UPC 00886874119747
Software version P1.2.1
The hazard
According to the FDA, an error event following the release of a software version for the surgical system can result in loss of user interface content on an external monitor or tower monitor.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Recent brand recalls include a Da Vinci 5 dV5 Tower NIR Handheld Camera recall on April 24, 2026, and an Intuitive Surgical Da Vinci Surgical System recall regarding E-Brake Pin Risk on April 22, 2026. Other recent recalls of similar products include Howmedica Stryker CranialMask Tracker (November 12, 2025), GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026), and Alphatec SafeOp Patient Interface Software Issue (May 13, 2026).
How to tell if you have this one
Check for the model number 380730 on the Da Vinci 5 system. Affected units have UDI-DI: 00886874119747 and software version P1.2.1.
Brand
Intuitive Surgical
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Da Vinci 5 system; affected units have version P1.2.1.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US distribution: LA, MA, NY, PA, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is for a software error that may cause monitor content loss, but it does not pose a risk of serious injury or death. The hazard is low risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1428-2026 (November 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1428-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.