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Boston Scientific Corporation recalls FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals fr
Recalled September 20, 2017 · FDA recall Z-3132-2017 · Boston Scientific
Hazard
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. · FDA Class II
Units
3
Sold at
US Distribution to one customer in Missouri.
Description
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Product
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →