Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors
[RECALL]Jul 26, 2019 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Jul 26, 2019
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 X and Xi systems over defective VSC/PSC capacitors that could cause loss of the 3D vision view or system errors. Paired recalls: X (52 systems) and Xi (123 systems). Source: FDA Class 2 device recalls Z-0926-2020 and Z-0925-2020, 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=179352
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=179352
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Details
Incident Context & FAQ
What happened in Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors?
Intuitive recalled da Vinci X and Xi systems over defective VSC/PSC capacitors that could cause loss of the 3D vision view or system errors. Paired recalls: X (52 systems) and Xi (123 systems). Source: FDA Class 2 device recalls Z-0926-2020 and Z-0925-2020, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on July 26, 2019 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 and Xi systems over defective capacitors that can cause vision loss or system errors?
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 and Xi systems over defective capacitors that can cause vision loss or system errors?
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 and Xi systems over defective capacitors that can cause vision loss or system errors?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.