Ion Endoluminal System recall
Ion Endoluminal System, REF: 380748-65
Why was Ion Endoluminal System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
- Product
- Ion Endoluminal System, REF: 380748-65
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ and CA.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)