| | Class 3 Recall
Medtronic Paceart |  |
| Date Posted |
November 06, 2007 |
| Recall Number |
Z-0081-2008 |
| 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 |
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
|
| 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. |
| |
|
|
|
|
