Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)
[RECALL]Sep 4, 2024 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Sep 4, 2024
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA Class II recall Z-2720-2024 (posted 2024-09-04): instrument-cart-arm screw issue in the Intuitive Ion Endoluminal System associated with potential uncontrolled instrument-arm motion.
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?start_search=1&recallnumber=Z-2720-2024
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&recallnumber=Z-2720-2024
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Details
Incident Context & FAQ
What happened in Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)?
FDA Class II recall Z-2720-2024 (posted 2024-09-04): instrument-cart-arm screw issue in the Intuitive Ion Endoluminal System associated with potential uncontrolled instrument-arm motion.
When did this incident occur?
The incident is recorded as occurring on September 4, 2024 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 Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)?
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 Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.