Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios
[RECALL]Mar 31, 2017 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Mar 31, 2017
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 the da Vinci Xi EndoWrist Suction Irrigator (REF 480299-03) because unexpected robotic-arm motion could occur under specific software scenarios. 90 units. Source: FDA Class 2 device recall Z-1819-2017, openFDA enforcement / accessdata.fda.gov.
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=167388
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=167388
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Details
Incident Context & FAQ
What happened in Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios?
Intuitive recalled the da Vinci Xi EndoWrist Suction Irrigator (REF 480299-03) because unexpected robotic-arm motion could occur under specific software scenarios. 90 units. Source: FDA Class 2 device recall Z-1819-2017, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on March 31, 2017 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 Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios?
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 Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios?
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 Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.