Reported Jan 18, 2023 · Ongoing
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN:…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor
- PN989803137631
- Lot codes and dates
- UDI(01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022
- Amount recalled
- 69,679 cases (1,741,975 units)
Where it was sold
- Nationwide
- PR
Why it was recalled
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 distribution of this product.
This product could cause temporary or reversible health problems — stop using it.
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