FDANovember 21, 2022device
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
philips north americaphilipsphilips north
UPCs
20884838007431989803137631
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- CPSCPetzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
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