Company:Boston Scientific Corporation.
Date of Enforcement Report 9/20/2017
ClasslI:
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
Recall Number Z-3132-2017
REASON
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation,MJarlborough, MA on 5/15/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
Missouri
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