Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
Medical device recall Z-1813-2016. Published in FDA’s Enforcement Report on Jun 1, 2016.
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 Jun 1, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 5875 (2685 in US; 3190 ROW) 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?
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
5875 (2685 in US; 3190 ROW), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M,…
Every code shown here, 1,997 characters
Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M, 807300015-J, 804200014-R,804200014, 807400010, 804200001-R, 806300001-R, 807300015-RF,804200001-E, 806300001-R, 806300026, 807300001-R, 806300007,807300015 Serial Numbers: 101951631001,05207007001,101950286001,05207131001,05627, 05206042001, 0520641200, 1101950547001, 101950181001, 05206363001, 101950277001, 101951298001, 05207035001,05339,101950590001, 05206734001,101950229001,05206884001,102120770001,101950240001, 101950843001,105206471001,101950244001,05206115001,05206046001 05660,05036,06804119001,05205021001,06802011001,101950285001 101950192001 06801062001 102500002001 05208721001 05208168001 101950619001 05320041001 101951238001 05206001001 05206188001 101951628001 05208457001 05028 101950239001 977299 GREG RAUCH 6942 E. HUNTING HOLLOW CT 101950614001 101951308001 05206726001 05208267001 101950671001 05208316001 05014 06802001001 06802003001 05208369001 05206949001 05208371001 06802004001 06802004001 101950678001 05206033001 06802202001 06802893001 101950045001 05303126001 06802035001 06801009001 101950178001 06801004001 06801019001 06801018001 06801063001 05304085001 05208185001 05304027001 06801731001 101950118001 101951303001 05206414001 05208001001 05031 05206441001 05656 05206054001 05206070001 06802200001 05206824001 05304084001 101950618001 05667 05208328001 101951633001 101950617001 05206062001 06801413001 101950204001 06801166001 102120066001 102120067001 102120003001 102120052001 06804578001 101950795001 102120939001 05343 05432 06801371001 06803918001 05530 05206682001 05206216001 05304091001 101951620001 05206063001 06801233001 101950084001 101950082001 05206479001 05682 101950235001 9775006804470001 05208621001 05304099001 102120618001 102120916001 06804520001 05206595001 05304102001 05206787001 9705533 977102120835001…
FDA’s list runs to 4,439 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: US (nationwide) and countries of: Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea, Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,
These words name no state.
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 Apr 25, 2016.
- FDA classified it on May 25, 2016.
- FDA’s Enforcement Report published it on Jun 1, 2016.
- FDA terminated it on Jan 2, 2018.
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 4,439 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
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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.