FDA recall Z-2720-2024

Product

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

US Nationwide distribution in the states of AZ and CA.

Key facts

Status

Ongoing

Initiation date

2024-07-12

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2024