medical LOW RISK Updated 2022-04-20

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

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Recalled Product

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

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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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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