Reported Sep 4, 2024 · Ongoing
Ion Endoluminal System, REF: 380748-65
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Ion Endoluminal System
- REF380748-65
- Lot codes and dates
3 of 3 products · 3 lot codes
Recalled lot codes, grouped by product number Serial Number System Cart Serial Number EN123010591271
EN124110591273
EN123110583014
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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