Class 3 Device Recall IntraSight Mobile IVUS System

• Date Initiated by Firm: January 24, 2022
• Create Date: April 09, 2022
• Recall Status: Open, 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: 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