FDA Enforcement
Class II
Ongoing
Ion Endoluminal System, REF: 380748-65
Recall: Z-2720-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2720-2024
- Event ID
- 95046
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- July 12, 2024
- Classification Date
- August 23, 2024
- Address
- 1266 Kifer Rd, Sunnyvale, CA, 94086-5304, United States
Description
Ion Endoluminal System, REF: 380748-65
Reason
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.
Code Info
UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
Distribution
US Nationwide distribution in the states of AZ and CA.
Quantity
3 units