Recall Z-0901-2022— Volcano Corp
Class III · Ongoing
Class III FDA medical device recall by Volcano Corp, initiated 2022-01-24. It names one FDA 510(k) clearance: K203719. 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..
- Recalling firm
- Volcano Corp
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-01-24
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.