Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- 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 distribution of this product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Product Codes/Lot Numbers:
UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0908-2023
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