Z-2720-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- July 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Ion Endoluminal System, REF: 380748-65
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 Pattern
US Nationwide distribution in the states of AZ and CA.
Code Information
UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014