Reported Apr 20, 2022 · Ongoing
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Volcano Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328
Is this the product you have?
- IntraSight Mobile IVUS Systems
- Model797415
- Part numbers
300002018101300002018102
- Lot codes and dates
- All MM-TSM units
- Device Identifier (DI)00845225012915
- Amount recalled
- 47
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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