Lower risk Medical device recall · FDA · Published January 19, 2022

Volcano SyncVision 400-0100.10 Software Version 4.2.x Recall: Incorrect iFR/FFR

Volcano recalls SyncVision Systems with software version 4.2.x due to potential incorrect iFR/FFR co-registration results, which could lead to inappropriate patient treatment. Affected units have specific serial numbers and software versions.

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

🇺🇸 FDA recall #Z-0885-2022Medical device Volcano ›

Lower-risk recall

If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

Take action

Contact the company

Recalling firmVolcano Corporation2451 Mercantile Dr · Rancho Cordova, CA 95742-6326

✎ GovInfoNow plain-language explainer

Volcano is recalling SyncVision Systems model 400-0100.10 with software version 4.2.x. This recall happens because the software might show incorrect iFR/FFR measurements during certain procedures, which could lead to wrong patient treatments. The issue is fixed by updating the system manual with workflow alternatives. Read more at govinfonow.com/recall/61252-volcano-syncvision-400-0100-10-software-version-4-2-x.

Source Summary by GovInfoNow · govinfonow.com/recall/61252-volcano-syncvision-400-0100-10-software-version-4-2-x · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0885-2022

Cite this page

“Volcano SyncVision 400-0100.10 Software Version 4.2.x Recall: Incorrect iFR/FFR.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61252-volcano-syncvision-400-0100-10-software-version-4-2-x. Based on FDA recall #Z-0885-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0885-2022%22&limit=1).

The FDA announced on Jan. 19, 2022, that Volcano Corporation is recalling SyncVision Systems with software version 4.2.x due to potential incorrect iFR/FFR co-registration results. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Volcano
Product: SyncVision Systems
Model: 400-0100.10
Part Number: 30000485688x
Software version: 4.2.x
Device Identifier: 00845225012434
Quantity: 3,216 units

The hazard

According to the FDA, if FFR measurements are made prior to an iFR/FFR co-registration/pullback in the same procedural session, incorrect results may be displayed. This error could lead users to mistakenly use incorrect measurements, potentially causing inappropriate patient treatment.

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 Volcano FFR Software Recall (Nov. 7, 2018), Volcano PV .035 Digital IVUS Catheter Recall (Oct. 17, 2018), and Philips Volcano CORE M2 Vascular System Recall (March 22, 2018). Other recent recalls of similar products include Merge PACS Workstation Software Inaccurate Measurements Recall (July 22, 2026), Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026), and Datascope Cardiosave Hybrid Recall (Oct. 23, 2025).

How to tell if you have this one

Check for the SyncVision model 400-0100.10 with software version 4.2.x and IntraSight IVUS software version 5.x. The device identifier (DI) 00845225012434 is specific to this recall.

Brand
Volcano
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Update System Manual
Review the updated Image Acquisition and Processing System Operators Manual for workflow alternatives to prevent incorrect measurements.

Where it went and when

Where it was distributed

Distributed in 43 states and D.C..

FDA distribution: “US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 19, 2022Firm started the recall
Apr 6, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/61252-volcano-syncvision-400-0100-10-software-version-4-2-x">Volcano SyncVision 400-0100.10 Software Version 4.2.x Recall: Incorrect iFR/FFR (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-0885-2022 (January 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0885-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.