Recall Z-0908-2023— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2022-11-21. It names one FDA 510(k) clearance: K030691. Product: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631. 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..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-21
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.