Intuitive Surgical, Inc.: 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.

Details from the source

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. Quantity: 3 units Lot/code info: UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

UPC codes

00886874116234

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.