Sep

2017

Cl II FFR Link-FFR Signal Processing Module

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II FFR Link-FFR Signal Processing Module

Amy Sellers

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