Device recall
Z-0911-06: Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of…
FDA device recall · Class III · Medtronic Inc. Cardiac Rhythm Managment
Key facts
| Recall number (Z-number) | Z-0911-06 |
|---|---|
| Recall event | 35141 |
| Product | 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… |
| Product code | DPS |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Managment |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 31, 2006 |
| 510(k) numbers | K024278 |
| FEI number | 2182208 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database