Summary
The FDA issued a Class II for Ion Endoluminal System, REF: 380748-65 by Intuitive Surgical, Inc.. 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 m.
Details
Source
Device Recall
External ID
Z-2720-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Ion Endoluminal System, REF: 380748-65
Lot/Code Info: UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
Quantity Affected: 3 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-12
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2720-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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