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Health Canada Medical devices

Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator

Issued October 17, 2023
Issue
Boston Scientific Corporation (BSC) is initiating a product advisory notification for the Emblem S-ICD pulse generator and Emblem MRI S-ICD pg to inform customers that a software update for the Emblem S-ICD is available to correct the potential for a rare interaction between the Emblem S-ICD and latitude communicator, which may cause S-ICD sensing disablement for a 24-hour interval. Recall start date: October 2, 2023
Hazard description
Performance
Product
Product name
Emblem S-ICD Pulse Generator and Emblem MRI S-ICD Pulse Generator
Reference
ID
RA-74433