Reported Apr 20, 2022 · Ongoing
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used…
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?
- MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller)
- Part Numbers
300002018101300002018102used
- with IntraSight Integrated (Part Number797403) IVUS systems
- Lot codes and dates
- MM-TSMs with bottom protective beams
- Amount recalled
- 1358
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), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.
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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