Reported Apr 13, 2022 · Ongoing
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2451 Mercantile Dr · Rancho Cordova, CA · 95742-6326
Is this the product you have?
- SyncVision Systems
- Model400-0100.10
- PN
30000485688xwith software version 4.2.x
- Lot codes and dates
- All serial numbers
- limited to cases whenThe SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x
- Device Identifier (DI)00845225012434
- Amount recalled
- 3,216
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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