FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field
[RECALL]Feb 18, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Feb 18, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA classified Class 2 recall for da Vinci 5 (IS5000). Viewer Display manufactured with outdated firmware may result in loss of one display and loss of 3D surgical field depth perception. Recall Z-1428-2026.
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
Related Incidents & Failure Precedents
6 records on file- Zoox recalls entire 105-vehicle fleet after robotaxi drove into smoke-filled active fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Phoenix
Details - Zoox recalls entire 105-vehicle fleet because robotaxis may not detect heavy smoke and could impede emergency responders[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis after vehicle drove into heavy smoke at active Las Vegas fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox issues software recall after robotaxi drove through heavy smoke at Las Vegas emergency scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis over failure to detect heavy smoke (NHTSA 26E044)[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Waymo recalls nearly 3,800 robotaxis over freeway construction zone risks[RECALL]
Jun 30, 2026 · Waymo · Waymo Driver (6th gen) · Sacramento, California, USA
Details
Incident Context & FAQ
What happened in FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
FDA classified Class 2 recall for da Vinci 5 (IS5000). Viewer Display manufactured with outdated firmware may result in loss of one display and loss of 3D surgical field depth perception. Recall Z-1428-2026.
When did this incident occur?
The incident is recorded as occurring on February 18, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
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 FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.