Philips North America, LLC recalls Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 98980
Recalled 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
Hazard / Issue
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.
Issued by
FDA
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