Medical device recalls Moderate risk

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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