Recall Z-0908-2023 · HGP Electrode, Circular (Spiral), Scalp And Applicator
Philips North America Llc
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
| Date | Jan 6, 2023 (initiated Nov 21, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Respo |
| Quantity | 69,679 cases (1,741,975 units) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Croatia, Cura¿ao, Czechia, Denmark, Faroe Islands, Finland, France, Germany, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Malaysi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 Clinical Innovations, Inc., Sep 17, 2003 |