Recall Z-0081-2008 ยท DPS Electrocardiograph
Medtronic Inc. Cardiac Rhythm Managment
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.
| Date | Nov 6, 2007 (initiated Aug 27, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 721 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024278 | PACEART SYSTEM Medtronic Vascular, May 29, 2003 |