Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement

[RECALL]

Jul 1, 2022 · Intuitive Surgical · da Vinci (and Ion) · South Korea

Failure Mode

RECALL

Event Date

Jul 1, 2022

Primary Entity

Intuitive Surgical

Robotic Platform

da Vinci (and Ion)

Jurisdiction / Location

South Korea

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

Intuitive recalled da Vinci Clip Appliers because partial disengagement could cause unexpected instrument motion during surgery. Two paired recalls: X/Xi (90,628 units) and S/Si (62,895 units). Source: FDA Class 2 device recalls Z-1460-2022 and Z-1459-2022, accessdata.fda.gov / openFDA enforcement.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=194426

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=194426

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement?

Intuitive recalled da Vinci Clip Appliers because partial disengagement could cause unexpected instrument motion during surgery. Two paired recalls: X/Xi (90,628 units) and S/Si (62,895 units). Source: FDA Class 2 device recalls Z-1460-2022 and Z-1459-2022, accessdata.fda.gov / openFDA enforcement.

When did this incident occur?

The incident is recorded as occurring on July 1, 2022 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 recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement?

da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.

Has anyone responded to Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement?

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 recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement?

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