Z-2043-2015Class II

Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5...

Name: Z-2043-2015 Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5...
Creator: Volcano Corp
Published: 2013-09-23
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2013-09-23 / Terminated / root cause: manufacturing process

FDA source

Volcano Corp began a recall of Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE... on 2013-09-23. FDA classified it as Class II and gives the reason as "A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2043-2015
Classification: Class II
Status: Terminated
Initiated: 2013-09-23
Posted: 2015-07-08
Terminated: 2015-07-09
Recalling firm: Volcano Corporation
Product: Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.
Quantity in commerce: 227 total units affected by the issue - all models
Distribution: Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Product codes and lots: s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2043-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2043-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08
Z-2044-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08
Z-2045-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)