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U.S. Department of Health and Human Services

Class 3 Device Recall Latitude Patient Management System

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 Class 3 Recall
Latitude Patient Management System
see related information
Date Posted February 23, 2012
Recall Status1 Terminated on October 25, 2012
Recall Number Z-1096-2012
Recall Event ID 60945
Premarket Approval
PMA Number
P910077
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Information Software version 7.2
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
FDA Determined
Cause 2
DESIGN: Software Design
Action Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
Quantity in Commerce 1
Distribution Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CLONMEL LIMITED
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CORPORATION
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC-CRM
PMAs with Product Code = LWS and Applicant = CARDIAC PACEMAKERS, INC.
PMAs with Product Code = LWS and Applicant = GUIDANT CORP.
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