Device recall
Z-0330-2013: Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp…
FDA device recall · Class II · Vital Signs Devices, a GE Healthcare Company
Key facts
| Recall number (Z-number) | Z-0330-2013 |
|---|---|
| Recall event | 63481 |
| Product | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. |
| Product code | HGP |
| Recalling firm | Vital Signs Devices, a GE Healthcare Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| 510(k) numbers | K792669 |
| FEI number | 2242551 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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