Software versions prior to 2.04 show a waveform while in suspend processing, while software version 2.04 and above do not show a waveform. Both software versions show an error message stating "ECG processing suspended" in the waveform zone, "?" in the heart rate, SpO2, and ST segment values, and a message stating "ECG ALM off" will replace the alarm limits. Hospitals may have multiple products concurrently running multiple software versions. The causal chain would be the user who is unaware of the different versions failing to recognize suspend state due to the presence of the waveform, leaving the patient in suspend with alarms inactive, a cardiac event occurring, and user failing to detect the condition with alarms inactive. Recall start date: May 23, 2023
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