FDA-Device2022-04-20Class III
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Volcano Corp
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.
Sold states
US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
Affected count
47
Manufactured in
3721 Valley Centre Dr Ste 500, N/A, San Diego, CA, United States
Products
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2022Don't want to check this manually?
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