Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals
[RECALL]Jun 10, 2020 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Jun 10, 2020
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 Ion Catheter Reprocessing Cover IF1000 (REF 490114-02) because cover disengagement or incorrect engagement could retain cleaning chemicals on the reprocessed catheter. 67 units. Source: FDA Class 2 device recall Z-2949-2020, 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=181839
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=181839
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Details
Incident Context & FAQ
What happened in Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals?
Intuitive recalled the Ion Catheter Reprocessing Cover IF1000 (REF 490114-02) because cover disengagement or incorrect engagement could retain cleaning chemicals on the reprocessed catheter. 67 units. Source: FDA Class 2 device recall Z-2949-2020, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on June 10, 2020 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 Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals?
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 Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.