Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2043-2015·Announced 2015-07-15

Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.

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, but the hazard is a software interoperability limitation affecting data calculation rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Volcano Corp is recalling 227 units of the Volcano s5, s5x, and CORE Mobile 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 the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. The affected units were distributed worldwide, including the United States, Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines, and Thailand.

Healthcare providers should contact Volcano Corp for further instructions regarding the recall and potential workarounds or repairs.

The recalled product

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…
Manufacturer: Volcano Corp
Category: Medical Device — Cardiovascular Imaging
Hazard: software-interoperability
data-accuracy
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)

s5 Part number 804200-002 and 804200-014
s5x Part number 807300-001
CORE MOBILE Part Number 400-0100.01. 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