Intuitive Surgical, Inc. recalls Ion Endoluminal System, REF: 380748-65
- Recall date
- July 12, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2720-2024
- FDA classification
- Class II
- Brand / firm
- Intuitive Surgical, Inc.
- Sold / distributed
- US Nationwide distribution in the states of AZ and CA.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ion Endoluminal System, REF: 380748-65
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