FDAJuly 19, 2019device
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
What to do
FDA enforcement status: Terminated
Brands named
philips north americaphilipsphilips north
UPCs
989803173131
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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