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U.S. Department of Health and Human Services

Class 3 Device Recall IntraSight Mobile IVUS System

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  Class 3 Device Recall IntraSight Mobile IVUS System see related information
Date Initiated by Firm January 24, 2022
Create Date April 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-0901-2022
Recall Event ID 89677
510(K)Number K203719  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Code Information All MM-TSM units, Device Identifier (DI): 00845225012915
Recalling Firm/
Manufacturer		 Volcano Corp
3721 Valley Centre Dr Ste 500
San Diego CA 92130-3328
For Additional Information Contact Emily Dentler
619-380-1318
Manufacturer Reason
for Recall		 Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
FDA Determined
Cause 2		 Error in labeling
Action On 01/24/22, correction notices were sent to customers who were informed that the recalling firm will notify all affected customers and arrange for a Field Service Engineer (FSE) to replace the MM-TSM free of charge. In addition, customers were asked to do the following: 1) Distributors or customers who have forwarded affected devices to other end users were asked to, send a copy of the correction notification to any customer to whom they have distributed affected devices to. 2) Customers were asked to complete and return customer response forms. 3) Customers with additional questions were encouraged to contact their local firm representative or contact IGTD Customer Service: Phone: 1-800-228-4728, Option 2, Email: igtd.remotesupport@philips.com, Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST
Quantity in Commerce 47
Distribution US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYO and Original Applicant = Volcano Corporation
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