Recall Z-0911-06 ยท DPS Electrocardiograph
Medtronic Inc. Cardiac Rhythm Managment
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken
| Date | May 31, 2006 (initiated Feb 2, 2006) |
| Status | Terminated |
| Reason | The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists. |
| Root cause | Other |
| Action | Affected user and potential users of the Gateway product were notified via phone and/ or a customer notification. The notification offers interim options until a software update is available. Customers are asked to respond back to Metronic with an enclosed Acknowledgement form. |
| Quantity | 210 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024278 | PACEART SYSTEM Medtronic Vascular, May 29, 2003 |