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Health Canada Medical devices

Cardiomems Patient and Hospital Electronics System

Issued February 23, 2023
Issue
Abbott has identified that when the Cardiomems Patient Electronics Systems (model CM1100) and Cardiomems Hospital Electronics Systems (HES) (model CM3000) are used to take a reading with the pulmonary artery (pa) sensor, the radiofrequency (RF) emissions at certain frequencies are higher than levels listed in the instructions for use (IFU). Recall start date: February 7, 2023
Hazard description
Performance
Product
Product name
Cardiomems Patient and Hospital Electronics System
Reference
ID
RA-72928