Volcano Corporation - 121020083482
Volcano Corporation 121020083482
Lower-risk recall
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Contact the company
What happened, in plain English
Volcano Corporation 121020083482 Read more at govinfonow.com/recall/72619-volcano-corporation-121020083482.
Source Summary by GovInfoNow · govinfonow.com/recall/72619-volcano-corporation-121020083482 · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0189-2018
Cite this page
“Volcano Corporation - 121020083482.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72619-volcano-corporation-121020083482. Based on FDA recall #Z-0189-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0189-2018%22&limit=1).
Why it’s dangerous
This product is a low risk to the public. It is a standard product from Volcano Corporation.
Who’s affected
All
How to tell if you have this one
Check for the product code 121020083482 on the packaging or label.
- Brand
Volcano Corporation- Category
Medical device
What to do — step by step
1. Check the product code
Look for the product code 121020083482 on the packaging or label of the product.
2. Verify the manufacturer
Ensure the product is manufactured by Volcano Corporation.
3. Confirm the product type
This product is a standard product from Volcano Corporation, so it is safe to use.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution including US nationwide and Canada, AE, AT, AU, BD, BE, BG, BR, CH, CL, CN, CY, DE, DK, EG, ES, FR, GB, HU, IE, IL, IN, IT, JO, JP, KW, KR, LB, MA, MX, MY, NL, NO, PA, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, Sri…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0189-2018 (November 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0189-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.