Drug recall
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN…
FDA recall event 91220 · Class II · Philips North America Llc
Key facts
| Event ID | 91220 |
|---|---|
| Recall numbers | Z-0908-2023 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the… |
| Initiation date | Nov 21, 2022 |
| Report date | Jan 18, 2023 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: