IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

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.

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: [email protected], Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST