Date Initiated by Firm |
August 27, 2007 |
Date Posted |
November 06, 2007 |
Recall Status1 |
Terminated 3 on November 03, 2008 |
Recall Number |
Z-0081-2008 |
Recall Event ID |
39422 |
510(K)Number |
K024278
|
Product Classification |
trans-telephonic pacemaker evaluation system - 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 MN 55432-3568
|
For Additional Information Contact |
763-514-4000
|
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 |
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
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DPS and Original Applicant = MEDTRONIC VASCULAR
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