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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.

Recall for EV1000 system with software version 0.1.1.52, Edwards Lifesciences , Download_VeroeffentlichtAm_EN PDF, 64KB, File does not meet accessibility standards