IntraSight Mobile IVUS Systems recall: Labeling Error
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Why was IntraSight Mobile IVUS Systems 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All MM-TSM units, Device Identifier (DI): 00845225012915
- Product
- IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- Recalling firm
- Volcano Corp
- Quantity
- 47
- Distribution
- US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
- Recall date
- April 20, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)