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FDAJanuary 19, 2022device

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

volcano

UPCs

00845225012434

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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