Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display
[RECALL]Nov 17, 2025 · Intuitive Surgical · da Vinci (and Ion) · Hong Kong, China
Failure Mode
RECALL
Event Date
Nov 17, 2025
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
Hong Kong, China
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed).
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217883
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217883
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Details
Incident Context & FAQ
What happened in Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed). FDA-determined cause: Software Design Change. 12 units in commerce across 6 US states. Corrective patch P1.2.2 in development.
When did this incident occur?
The incident is recorded as occurring on November 17, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at Hong Kong, China.
Has anyone responded to Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.