Z-2720-2024 Class II Ongoing
FDA device recall Z-2720-2024 was initiated by Intuitive Surgical, Inc. on Jul 12, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2024
- Initiation Date
- Jul 12, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2720-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026