Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue
Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a functional defect (impeded measurement) rather than a direct physical injury risk.
Plain-English summary
Philips North America, LLC is recalling 280 boxes (5,600 leadsets) of Philips 5-Lead Set, Disposable, Bedside, AAMI (Model # 989803173131). The affected products are single-patient-use ECG lead sets used for bedside monitoring.
The recall is due to a manufacturing defect where the thickness of the connector to the trunk cable may be greater than specified. This issue may prevent or impede the performance of I 2-Lead ECG measurements. The affected lot codes are 03/18, 05/18, and 06/18.
The products were distributed worldwide, including in the US (KY, AZ, CA, UT, OH, NY, SC, CO, FL, IN, TX, ND, KS, GA), Canada, and Germany. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- 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
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — ECG Lead Sets
- Hazard
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 (2)
- Lot codes: 03/18
- 05/18 and 06/18
Distribution
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