Device recall
Z-0041-2012: ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series…
FDA device recall · Class II · Edan Instruments, Inc.
Key facts
| Recall number (Z-number) | Z-0041-2012 |
|---|---|
| Recall event | 59418 |
| Product | ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only… |
| Product code | DPS |
| Recalling firm | Edan Instruments, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2011 |
| 510(k) numbers | K091513 |
| FEI number | 3003971136 |
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