Important Product Notice
Recall Number: 2021-CC-HPM-085

Philips has discovered an issue related to the orientation of the internal wiring of the Philips 12-Lead Chest Leadset (AAMI/IEC).

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What the problem is and under what circumstances it can occur

The V1 and V3 leads in the Philips 12-Lead Chest Lead-set (AAMI/IEC) were incorrectly assembled. The internal wiring of V1 and V3 leads being incorrectly positioned (swapped) in the Lead-set hub generates the wrong electrocardiogram (ECG) report and potentially the wrong interpretation of the results on both the 989803151671 (12-Lead Chest Lead-set (AAMI/IEC), Std) and 989803151691 (12-Lead Chest Lead-set (AAMI/IEC), Long). The swapped Lead-set issue is only applicable for the PageWriter TC70, TC50, and TC30 cardiographs.

 

The Philips 12-Lead Chest Lead-set (AAMI/IEC) is intended to be used in hospitals and physician office environments to transmit electrical signals from electrodes placed on the patient's body to the electrocardiograph (ECG) machine. Upon setting up the electrocardiogram (ECG), there is no indication that the V1 and V3 leads have been swapped. Thus, the user will not know the lead wires are incorrectly assembled until an inaccurate electrocardiogram (ECG) result is produced.

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Affected Products are identified below: