FDAFDA · Food and drugs·Recall number Z-2720-2024
Ion Endoluminal System, REF: 380748-65
Published September 4, 2024 · Recall initiated: July 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- US Nationwide distribution in the states of AZ and CA.
- Lot
- UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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