Device recall
Z-0743-2012: Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The…
FDA device recall · Class II · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-0743-2012 |
|---|---|
| Recall event | 60803 |
| Product | Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to… |
| Product code | DPS |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2012 |
| 510(k) numbers | K090367 |
| FEI number | 3002807992 |
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