Volcano Imaging System s5i
Medical device recall Z-0189-2018. Published in FDA’s Enforcement Report on Dec 6, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 6, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 5 states named
- 1166 Units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
1166 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Version v3.5 software; Serial Numbers - 121020092284 103020086507 121070065001 103070097001 103070103001 103020087167 121070003001 103020092291 121020089611 103020086243 103020096244 103070057001 121020091839 121020093104 103020087187…
Every code shown here, 1,990 characters
Version v3.5 software; Serial Numbers - 121020092284 103020086507 121070065001 103070097001 103070103001 103020087167 121070003001 103020092291 121020089611 103020086243 103020096244 103070057001 121020091839 121020093104 103020087187 103060028001 103060031001 103060046001 103060062001 121000504001 103070035001 121020084117 103020086808 103070010001 103070131001 121020088317 121020095839 103020085911 103020085961 103020086037 103020086161 103020088008 103020097146 121020086872 121020091918 103020084248 103020084403 103020084446 121020084118 121020094522 121020083765 121020089513 103020091063 103020088002 121020088313 121020088314 121020088315 121020088001 103020083854 103000596001 103000597001 103020084875 103020095013 103060404001 103070029001 121020084415 121020088469 121070056001 121070057001 121070046001 103020083200 121020089671 103070036001 103070037001 121070041001 121070042001 121020083595 121020084767 103020092827 121020085705 121020093100 121020091471 103070069001 103020087956 121020084507 103020084133 121070001001 121070058001 103020090806 103020091107 103020088815 103070114001 103070115001 103070140001 103070141001 103020088818 103070148001 103070149001 121020084123 121020084124 121020088216 121020089333 121020095380 103020092277 103020092335 103020092385 103020091752 103020094264 103020096245 103020098272 121020090883 121020095394 121020083335 121020095451 103020089017 103020091348 103020092638 121020091914 121060315001 121060316001 103020092278 103020083301 103020090360 103020090458 121020089943 121020095609 103020094733 121020092725 103020093222 103020093296 103020095341 121020083594 121070047001 121020088470 103020083291 103020083292 103020083294 103020083295 121020095393 103020089299 103070129001 103070130001 121020084113 121020091797 103020092398 103020092457 121020095398 103020094499 103070014001 103020083365 103020087231 121020088215 121020088217 103020089290 103020089554 103020090803 103020083957 121020092213 121070020001 103070042001…
FDA’s list runs to 15,208 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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 Lanka, TH, TW, UAE, UK, ZA,
The states and territories these words name
- Delaware
- Illinois
- Indiana
- Massachusetts
- Pennsylvania
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2017.
- FDA classified it on Nov 29, 2017.
- FDA’s Enforcement Report published it on Dec 6, 2017.
- FDA terminated it on Oct 20, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Volcano Corporation, of Rancho Cordova, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 15,208 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.