da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component

[RECALL]

Feb 23, 2023 · Intuitive Surgical · da Vinci (and Ion) · South Korea

Failure Mode

RECALL

Event Date

Feb 23, 2023

Primary Entity

Intuitive Surgical

Robotic Platform

da Vinci (and Ion)

Jurisdiction / Location

South Korea

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

Recall RA-73120 (Class II; ~Feb 23 2023): a loose instrument carriage on the Universal Surgical Manipulator caused by a linear-rail component out of specification (carriage wobble under force) on da Vinci X (IS4200) and Xi (IS4000); CAPA 552131. Cap-flag: sourced via Health Canada's regulator mirror; exact unit count not captured.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://recalls-rappels.canada.ca/en/alert-recall/da-vinci-surgical-systems

    https://recalls-rappels.canada.ca/en/alert-recall/da-vinci-surgical-systems

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component?

Recall RA-73120 (Class II; ~Feb 23 2023): a loose instrument carriage on the Universal Surgical Manipulator caused by a linear-rail component out of specification (carriage wobble under force) on da Vinci X (IS4200) and Xi (IS4000); CAPA 552131. Cap-flag: sourced via Health Canada's regulator mirror; exact unit count not captured.

When did this incident occur?

The incident is recorded as occurring on February 23, 2023 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 recall: loose instrument carriage from an out-of-spec linear-rail component?

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 recall: loose instrument carriage from an out-of-spec linear-rail component?

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 recall: loose instrument carriage from an out-of-spec linear-rail component?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.