Volcano Corp Recall 89677
Description: IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Volcano Corp Recall 89677 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0901-2022 |
| Event ID | 89677 |
| Event Description | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 |
| Product Type | Devices |
| Distribution | US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT |
| Quantity | 47 |
| Recall 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. |
| Device Classification | 20220420 |
| Device Code Info | All MM-TSM units, Device Identifier (DI): 00845225012915 |
| Center Classification Date | 20220408 |
| Recall Initiation Date | 20220124 |
| Recalling Firm | Volcano Corp |
| Initial Notification | Letter |
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