Philips Fetal Spiral Electrode may break off during labor monitoring
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II medical device recall where the broken components require surgical intervention to remove from neonates, constituting significant injury that meets the severe classification threshold.
Plain-English summary
Philips North America LLC is recalling the Fetal Spiral Electrode (model PN 989803137631), a medical device used to monitor fetal heart rate during labor. The spiral tip of the electrode can separate during clinical use, and when this occurs, the broken tip remains inside the patient and requires surgical intervention to remove.
Approximately 69,679 cases (1,741,975 units) were distributed worldwide between May 2020 and November 2022 to customers in the United States and numerous countries internationally. The affected units shipped to and were received by customers within this timeframe.
Healthcare providers and patients currently using this device should consult with Philips regarding their device serial numbers and lot information. Philips has discontinued production and distribution of this product.
The recalled product
- Product
- Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
- Manufacturer
- Philips North America Llc
Distribution
Distributed nationwide across the United States.
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