Ion Endoluminal System, REF: 380748-65
Reported: September 4, 2024 Initiated: July 12, 2024 #Z-2720-2024
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ and CA.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Ion Endoluminal System, REF: 380748-65. Recalled by Intuitive Surgical, Inc.. Units affected: 3 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2720-2024.
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