Z-1512-2020 Class II Terminated
FDA device recall Z-1512-2020 was initiated by Boston Scientific Corporation on February 12, 2020 and is designated Class II. 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 down… The recall status is terminated (terminated April 14, 2023). Affected quantity: 1 device.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 12, 2020
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 device
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution in the states of NC, TN, and MO.
Code Information
Serial Number 516959