Cardiohelp-I

During service measurements on the Cardiohelp-I devices in the field, it was noticed that the measured patient leakage current exceeded the limit values of 50 μa specified in standard EN 60601-1:2006 + a1:2013. Patient leakage currents of up to 1337 μa were measured. Investigations have shown that only Cardiohelp-I devices with installed sensor panels (701051308) with an old sensor bridge (701049193) hardware version are affected. The new hardware version is not affected.

Recall Start Date: March 18, 2024