da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use
[RECALL]Feb 2, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Feb 2, 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 recall Z-1232-2026 (Class II; initiated Nov 7 2025, classified Feb 2 2026): a software implementation error allowed Universal Surgical Manipulator instrument arms that FAILED a diagnostic (designed to detect bent/misaligned insertion-axis ball screws, a fatigue-failure precursor) to remain in clinical use. No injuries reported. System-level recall.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://regdatalab.com/recall/Z-1232-2026
https://regdatalab.com/recall/Z-1232-2026
- Inspect Filing
https://softwarecpr.com/2026/02/fda-recall-software-implementation-error-led-to-instrument-arms-to-fail/
https://softwarecpr.com/2026/02/fda-recall-software-implementation-error-led-to-instrument-arms-to-fail/
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Details
Incident Context & FAQ
What happened in da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
FDA recall Z-1232-2026 (Class II; initiated Nov 7 2025, classified Feb 2 2026): a software implementation error allowed Universal Surgical Manipulator instrument arms that FAILED a diagnostic (designed to detect bent/misaligned insertion-axis ball screws, a fatigue-failure precursor) to remain in clinical use. No injuries reported. System-level recall.
When did this incident occur?
The incident is recorded as occurring on February 2, 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 da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
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 da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.