Boston Scientific Corporation recalls FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals fr…

Recall date

May 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3132-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

US Distribution to one customer in Missouri.

Why it was recalled

The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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