FDA-Device2024-09-04Class II
Ion Endoluminal System, REF: 380748-65
Hazard
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.
Sold states
US Nationwide distribution in the states of AZ and CA.
Affected count
3 units
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Ion Endoluminal System, REF: 380748-65
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2024More Intuitive Surgical, Inc. recalls
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Cautery Hook instruments recalled for frayed or broken cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Mega Needle Driver recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Grasping Retractor recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S and Si Monopolar Curved Scissors recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S, Si Double Fenestrated Grasper recalled for broken grip cables
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