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Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Recalled April 20, 2022 · FDA recall Z-0901-2022 · Volcano
Hazard
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. · FDA Class III
Units
47
Sold at
US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Description
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.
Product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Manufacturer(s)
Volcano Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →