FDA-Device2020-03-25Class II
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.
Boston Scientific Corporation
Hazard
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.
Sold states
US Nationwide distribution in the states of NC, TN, and MO.
Affected count
1 device
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2020Don't want to check this manually?
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