Class II
Medical Device Recall: Ion Endoluminal System, REF: 380748-65
Intuitive Surgical, Inc. · July 12, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AZ and CA.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2720-2024
Status: ongoing
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