Recall Z-0901-2022 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corp
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
| Date | Jan 24, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 47 |
| Distribution | US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203719 | IntraSight Mobile Volcano Corporation, Jan 19, 2021 |