Device recall
Z-0542-03: LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute…
FDA device recall · Class II · Medtronic Physio Control Corp
Key facts
| Recall number (Z-number) | Z-0542-03 |
|---|---|
| Recall event | 25289 |
| Product | LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient… |
| Product code | MKJ |
| Recalling firm | Medtronic Physio Control Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2004 |
| 510(k) numbers | K002445, K010918, K973486, K990338, K991910 |
| FEI number | 3015876 |
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