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U.S. Department of Health and Human Services

Class 2 Device Recall Ion Endoluminal System

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 Class 2 Device Recall Ion Endoluminal Systemsee related information
Date Initiated by FirmJuly 12, 2024
Date PostedAugust 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2720-2024
Recall Event ID 95046
510(K)NumberK182188 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductIon Endoluminal System, REF: 380748-65
Code Information UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
408-523-2443
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn July 12, 2024, Intuitive issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. An Intuitive Representative will schedule a site visit to perform replacement of the affected FIM assembly. Once replaced by the Intuitive Representative the Ion System can be used as designed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, regular mail, or fax.
Quantity in Commerce3 units
DistributionUS Nationwide distribution in the states of AZ and CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOQ
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