IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Reported: April 20, 2022 Initiated: January 24, 2022 #Z-0901-2022
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.
Details
- Recalling Firm
- Volcano Corp
- Units Affected
- 47
- Distribution
- US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102. Recalled by Volcano Corp. Units affected: 47.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Low. Recall number: Z-0901-2022.
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