medical Class III Updated 2022-04-20

Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers:

Recalled Product

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Hazard / Issue

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.

Issued by

FDA

Affected States: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN, DE
Lot/Code Info: All MM-TSM units, Device Identifier (DI): 00845225012915
View official government recall

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