FDA Device recall Z-0901-2022
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- FDA Device
- Class III
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class III recall of IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 by Volcano, citing 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: Uniqu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0901-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-01-24 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Volcano |
| Distribution | AZ, CA, CO, DE, FL, GA, MA, MD, MO, NC, NY, OR, PA, TN, TX |
Product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
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.
Identifiers
| code_info | All MM-TSM units, Device Identifier (DI): 00845225012915 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0901-2022%22
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