Philips North America Llc Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Philips Medical issued to U.S. customers, the Urgent Medical Device Correction (UMDC) letter via certified mail 11/21/22. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take. Philips has decided to discontinue the distribution of this product. To limit the potential for the spiral tip of the FSE to break off in the patient s scalp, it is important to avoid over rotation during attachment or pulling the tip from the fetal scalp Customer should complete the Urgent Field Safety Notice Response Form online to submit both their acknowledgement of this recall (mandatory) and actions taken, as well as request for credit (optional). To request credit go to URL: https://forms.office.com/r/GsLVh2gYZi Pass this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (If appropriate). If you choose, discard all FSEs sold by Philips and source from an alternative supplier available in your country. If you choose to discard the FSEs, we will issue a credit after you complete the online response form. Actions planned by Philips Hospital Patient Monitoring to correct the problem " Philips is continuing to investigate additional root causes with FSE supplier " Philips will immediately discontinue selling the FSEs " Philips will reimburse for any discarded FSEs