Device recall
Z-0908-2023: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-0908-2023 |
|---|---|
| Recall event | 91220 |
| Product | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 |
| Product code | HGP |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030691 |
| FEI number | 3016618143 |
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