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U.S. Department of Health and Human Services

Class 2 Device Recall FFR LinkFFR Signal Processing Module

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  Class 2 Device Recall FFR LinkFFR Signal Processing Module see related information
Date Initiated by Firm May 15, 2017
Create Date September 13, 2017
Recall Status1 Terminated 3 on July 06, 2021
Recall Number Z-3132-2017
Recall Event ID 77444
510(K)Number K170204  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
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
Code Information Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Boston Scientific sent an Important Medical Device Information letter dated May 30, 2017, to their affected consignee. On May 15, 2017, Boston Scientific visited the consignee and exchanged the affected device for a device that met specifications. The letter requested a response form be completed and returned. For questions customers should call 763-494-1133.
Quantity in Commerce 3
Distribution US Distribution to one customer in Missouri.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRG and Original Applicant = Boston Scientific Corporation
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