Device recall
Z-1350-2015: Skintact ECG Electrode FS-50, Catalog no. 58028, & Stable Base ECG Electrode…
FDA device recall · Class II · Leonhard Lang Medizintechnik GmbH
Key facts
| Recall number (Z-number) | Z-1350-2015 |
|---|---|
| Recall event | 70704 |
| Product | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram. |
| Product code | DRX |
| Recalling firm | Leonhard Lang Medizintechnik GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2017 |
| 510(k) numbers | K024247 |
| FEI number | 6736 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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