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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Paceart

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 Class 3 Recall
Medtronic Paceart
see related information
Date Posted November 06, 2007
Recall Status1 Terminated on November 03, 2008
Recall Number Z-0081-2008
Recall Event ID 39422
Premarket Notification
510(K) Number
K024278 
Product Classification Electrocardiograph - Product Code DPS
Product Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices.
Code Information Paceart System - 2006 First Edition (Get Connected Edition)
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Minneapolis, Minnesota 55432-3568
Manufacturer Reason
for Recall
An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting
FDA Determined
Cause 2
DESIGN: Software Design
Action A Medtronic letter was sent to consignees on 8/27/07. The letter described the issue and the product involved. It also notified customers that Medtronic is developing a software update that will correct the issue. An Acknowledgement form was attached to be filled by consignees as confirmation and understanding of the information received.
Quantity in Commerce 721
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = MEDTRONIC VASCULAR
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