Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2044-2015·Announced 2015-07-15

Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a software interoperability limitation affecting data calculation rather than a direct physical injury or high-risk pathogen.

Plain-English summary

Volcano Corp is recalling 227 units of the s5i, s5ix, s5iz, and CORE Intravascular Ultrasound Imaging and Pressure Systems. The recall is due to a limitation in interoperability between these Volcano systems and the Philips Xper Flex Cardia Physiomonitoring System.

This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when it is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. The affected units were distributed worldwide, including in the United States, Belgium, the United Kingdom, Denmark, the Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, the Philippines, and Thailand.

Healthcare providers and facilities should contact Volcano Corp for instructions on how to address this limitation. The recall covers all software versions of the affected product part numbers.

The recalled product

Product: Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular…
Manufacturer: Volcano Corp
Category: Medical Device — Cardiovascular Imaging
Hazard: software-interoperability
data-integrity
Affected units: 227

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Product/Part numbers: s5i -806300-020
s5ix/s5iz - 807400-001
CORE - 400-0 I 00.02. All software versions

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Volcano Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Volcano Corp

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Same hazard · software interoperability