IntraSight Mobile IVUS Systems — Class III medical device recall Z-0901-2022
Ongoing recall by Volcano Corp, reported 2022-04-20, distributed in AZ, CA, CO, FL, GA, MA, MD, MO…. Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobil
| Recall number | Z-0901-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corp, San Diego, CA, United States |
| Recall initiated | 2022-01-24 |
| Classified | 2022-04-08 |
| Reported by FDA | 2022-04-20 |
| Distributed | AZ, CA, CO, FL, GA, MA, MD, MO, NC, NY, OR, PA, TN, TX |
| Quantity | 47 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00845225012915 |
| Model numbers | 300002018101, 300002018102, 797415 |
Product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0901-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.