Philips Fetal Spiral Electrode Recall Due to Metal Tip Breakage Risk
Philips is recalling Fetal Spiral Electrodes because the metal tip may break off and remain in a newborn's scalp during delivery.
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: The recall is classified as FDA Class II and involves a structural defect (metal tip breakage) that results in a foreign object remaining in a patient's body, which aligns with the rubric for significant injury or structural defects.
Plain-English summary
Philips North America, LLC is recalling Fetal Spiral Electrodes, Model No. 9898 031 37631. The recall involves 1,971,925 units (78,877 boxes) that were distributed nationwide in the US and internationally.
The recall is issued because the metal electrode tip may break off during use and remain in the scalp of the newborn following labor and delivery. This hazard is associated with the use of the device during the delivery process.
Healthcare providers and consumers should stop using the affected devices immediately. The source text does not specify further instructions for disposal or replacement, but the risk of the tip remaining in the patient necessitates cessation of use.
The recalled product
- Product
- Fetal Spiral Electrode, Model No. 9898 031 37631
- Manufacturer
- Philips North America, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products currently in distribution.
Distribution
Distributed nationwide across the United States.
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