Recall for EV1000 system with software version 0.1.1.52, Edwards Lifesciences
2010.04.14
Product group Medical electronics / Electromedical devices
Reference 01198/10
Edwards Lifesciences has issued the Field Safety Notice that the EV1000 system with software version 0.1.1.52 is incorrectly calculating Systemic Vascular Resistance Index.
Edwards Lifesciences is initiating a Field Safety Corrective Action and requesting the users to immediately discontinue using the EV1000.