Z-3039-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- February 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 12,450 devices
Product Description
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Reason for Recall
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Distribution Pattern
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Code Information
All serial numbers