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U.S. Department of Health and Human Services

Class 2 Device Recall DYNAGEN EL ICD DR

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  Class 2 Device Recall DYNAGEN EL ICD DR see related information
Date Initiated by Firm February 12, 2020
Date Posted March 03, 2020
Recall Status1 Terminated 3 on April 14, 2023
Recall Number Z-1512-2020
Recall Event ID 85077
PMA Number P960040S306 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Code Information Serial Number 516959
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information Contact
800-227-3422
Manufacturer Reason
for Recall		 Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.
Quantity in Commerce 1 device
Distribution US Nationwide distribution in the states of NC, TN, and MO.
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 = LWS and Original Applicant = BOSTON SCIENTIFIC
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