Unrated Medical device recall · FDA · Published November 7, 2018

Philips Volcano FFR Software Recall: Interoperability Issues with Hemodynamic Systems

Philips Volcano FFR software used in specific imaging systems connected to Hemodynamic Systems may cause interoperability issues. Affected units include Volcano s5i, s5ix, and CORE Mobile Imaging Systems with certain part numbers. No remedy is stated in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0674-2020Medical device Volcano Corporation ›

Recall notice

Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

Take action

Contact the company

Recalling firmVolcano Corporation2870 Kilgore Rd · Rancho Cordova, CA 95670-6133

✎ GovInfoNow plain-language explainer

Philips Volcano FFR software for certain imaging systems connected to Hemodynamic Systems (HMS) has been recalled due to interoperability issues. This could cause system malfunctions when used with specific HMS models. The recall does not include a remedy as stated in the official notice. Read more at govinfonow.com/recall/69492-philips-volcano-ffr-software-recall-interoperability-issues-with-hemodynamic-systems.

Source Summary by GovInfoNow · govinfonow.com/recall/69492-philips-volcano-ffr-software-recall-interoperability-issues-with-hemodynamic-systems · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0674-2020

Cite this page

“Philips Volcano FFR Software Recall: Interoperability Issues with Hemodynamic Systems.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69492-philips-volcano-ffr-software-recall-interoperability-issues-with-hemodynamic-systems. Based on FDA recall #Z-0674-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0674-2020%22&limit=1).

The FDA announced on Nov. 7, 2018, that Volcano Corporation voluntarily recalled Philips Volcano FFR software due to an interoperability issue affecting connected Hemodynamic Systems, according to the FDA.

How to tell if you have it

Volcano Imaging System s5i, Part #807400001
s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200
s5i Imaging System, Part#806300003
s5i Imaging System, Part#5322466
s5x Imaging System, Part#807300001
s5x Imaging System Refurbished, Pat#807300001 R
s5 Imaging System Refurbished, Part#804200001 R
CORE Mobile Imaging System (120V), Part #400-0100.01
CORE Mobile Imaging System Refurbished, Part #400-0100.01-R
CORE Mobile Imaging System (240V), Part #400-0100.07
CORE Mobile Imaging System Refurbished, Part #400-0100.07-R
CORE Mobile Imaging System (100V), Part #400-0100.08
CORE Mobile Imaging System Refurbished, Part #400-0100.08-R
CORE Imaging System, Part #400-0100.02
CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.
FFR V2.5 Software Kit, Catalog 4536-010-57091 (Legacy 435-0602.48)
FFR V2.5 Update Installation Disk, Catalog 4536-010-52781 (Legacy 435-0100.98)

The hazard

The recall addresses an interoperability issue that affects certain systems using the recalled software when connected to specific Hemodynamic Systems, according to the FDA.

Context

GovInfoNow's records show Volcano Corporation has four other recalls on record since Nov. 3, 2017. Other recent recalls of similar products include Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall (June 17, 2026), Philips Allura Xper FD10 System Recall (April 30, 2026), and Philips Achieva 3.0T MRI Recalled (Aug. 21, 2026).

How to tell if you have this one

Check if your system includes the Volcano Imaging System s5i (Part #807400001), s5ix Imaging System (Part #807400001 R), or CORE Mobile Imaging Systems with specific part numbers listed in the recall notice. The software version is FFR V2.5 with Catalog numbers 4536-010-57091 or 4536-010-52781.

Brand
Volcano Corporation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify if your system uses FFR V2.5 software with Catalog numbers 4536-010-57091 or 4536-010-52781.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

Nov 7, 2018Firm started the recall
Dec 12, 2019FDA classified it Class II
Dec 18, 2019Published in FDA’s Enforcement Report
Jul 14, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Volcano Corporation recalls

Link to this recall

<a href="https://govinfonow.com/recall/69492-philips-volcano-ffr-software-recall-interoperability-issues-with-hemodynamic-systems">Philips Volcano FFR Software Recall: Interoperability Issues with Hemodynamic Systems (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0674-2020 (November 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0674-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.