Recall Z-0081-2018— Boston Scientific Corporation

Name: FDA recall Z-0081-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-04

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-10-04, terminated 2019-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: RESONATE X4 CRT-D, Model G447, Sterile.. Reason: The devices have an incorrect firmware configuration..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Terminated: 2019-10-15
Firm location: Saint Paul, MN, United States

Product description

RESONATE X4 CRT-D, Model G447, Sterile.

Reason for recall

The devices have an incorrect firmware configuration.

Data sourced from openFDA. This site is unofficial and independent of the FDA.