Field Safety Notice concerning a corrective action of the electrocardiogram (ECG) Screening software, Spacelabs Healthcare
2011.12.22
Product group Medical electronics / Electromedical devices
Reference 05363/11
Spacelabs Healthcare has issued a Field Safety Notice concerning a corrective action of the electrocardiogram (ECG) Screening software version 3.31. If Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System the file can get corrupted or a wrong ECG can occur. This can only happen if both recordings are greater than 32 hours long.