Volcano FFR Software Recalled for Interoperability Issues with Hemodynamic Systems
Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.
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, and the source text describes an interoperability issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Volcano Corporation is recalling the Philips Volcano FFR software used in various imaging systems, including the Volcano Imaging System s5i, s5ix, s5x, and CORE Mobile Imaging Systems. The recall affects 3,667 units with the software.
The recall is due to an interoperability issue that affects certain systems using the recalled software when connected to specific Hemodynamic Systems (HMS). The affected software includes the FFR V2.5 Software Kit and FFR V2.5 Update Installation Disk.
Distribution was nationwide, including government and military facilities, as well as foreign distribution to numerous countries. Users should contact Volcano Corporation for further instructions regarding the recall.
The recalled product
- Product
- Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and…
- Manufacturer
- Volcano Corporation
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3,667
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 (2)
- FFR V2.5 Software Kit
- Catalog 4536-010-52781 (Legacy 435-0100.98)
Distribution
Distributed nationwide across the United States.
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