BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice concerning a corrective action of the long-term electrocardiogram (ECG) analyzer Pathfinder, Spacelabs Healthcare

Product group Medical electronics / Electromedical devices
Reference 03097/11

Spacelabs Healthcare has issued a Field Safety Notice concerning a corrective action of the long-term electrocardiogram (ECG) analyzer Pathfinder. When using an ECG recorder with Sentinel V7.1.x and Pathfinder V9.019 there is the risk that the second 24 hours of a 48 hours ECG recording will not be analyzed and abnormal morphologies might not be identified.

Safety Notice concerning a corrective action of the long-term electrocardiogram (ECG) analyzer Pathfinder, Spacelabs Healthcare , Download_VeroeffentlichtAm_EN PDF, 33KB, File does not meet accessibility standards