Reason for Recall: The Kappa and Sigma pacemakers in these identified series may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
Reason for Recall: The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, CK-MB, and myoglobin, possibly resulting in missed or incorrect diagnosis.