Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 6/9/2021 Class II PRODUCT Change Healthcare Enterprise Viewer – Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Recall Number: Z-1773-2021 REASON A software defect was identified where the Image...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report: 6/9/2021 Class II PRODUCT Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 – Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Recall Number: Z-1690-2021 REASON Three separate and unrelated problems attributed to the software used in the...Read More

Company: Medtronic Date of Enforcement Report: 6/9/2021 Class II PRODUCT Multiple MiniMed 780G Insulin Pump Models Recall Number: Z-1771-2021 REASON Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active...Read More