Z-2134-2015Class II

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR...

Name: Z-2134-2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR...
Creator: Volcano Corporation
Published: 2015-06-22
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2015-06-22 / Terminated / root cause: software

FDA source

Volcano Corporation began a recall of Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i... on 2015-06-22. FDA classified it as Class II and gives the reason as "A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2134-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-22
Posted: 2015-07-20
Terminated: 2017-04-14
Recalling firm: Volcano Corporation
Product: Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
Quantity in commerce: A total of 4007 devices, all models
Distribution: Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina
Product codes and lots: Model s5i. Part number: 806300-020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2132-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2133-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2134-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2135-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2136-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code IYO

K123898Class IIVolcano S5/s5i Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation / cleared 2013-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)