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U.S. Department of Health and Human Services

Class 2 Device Recall RESONATE X4 CRTD

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  Class 2 Device Recall RESONATE X4 CRTD see related information
Date Initiated by Firm October 04, 2017
Create Date November 08, 2017
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-0081-2018
Recall Event ID 78323
PMA Number P010012 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product RESONATE X4 CRT-D, Model G447, Sterile.
Code Information Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
800-227-3422
Manufacturer Reason
for Recall		 The devices have an incorrect firmware configuration.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.
Quantity in Commerce 11 devices
Distribution The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = Boston Scientific Corp.
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