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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Patient Management System

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 Class 2 Recall
LATITUDE Patient Management System
see related information
Date Posted April 26, 2011
Recall Status1 Terminated on November 15, 2012
Recall Number Z-2052-2011
Recall Event ID 57744
Premarket Approval
PMA Number
P910077/S102
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Information Software Versions 6.x versions launched on June 6, 2010 or later.
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 has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a Boston Scientific "LATITUDE® Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.
Quantity in Commerce 25,836
Distribution Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
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-CRM
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