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.
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.
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.
The software may display incorrect iFR/FFR co-registration results if measurements are taken before a co-registration/pullback in the same procedure. This could lead to users applying inappropriate patient treatments based on faulty data. The issue is addressed by updating the system manual with alternative workflow steps.
Image acquisition and processing system operators using Volcano SyncVision Systems with software version 4.2.x and IntraSight IVUS software version 5.x are affected. The risk is low as the issue requires specific procedural steps to occur.
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.
Review the updated Image Acquisition and Processing System Operators Manual for workflow alternatives to prevent incorrect measurements.
Software version 4.2.x for SyncVision Systems and software version 5.x for IntraSight IVUS.
Check for the SyncVision model 400-0100.10 with software version 4.2.x and IntraSight IVUS software version 5.x, with device identifier 00845225012434.
Yes, the system manual will be updated with workflow alternatives to prevent incorrect measurements.
We’ve drafted a message you can send Volcano to request your refund or repair — edit it as you like.
Subject: Recall Z-0885-2022 — Volcano Volcano Hello, I own a Volcano that is covered by recall Z-0885-2022 from Volcano. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
