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Health Canada Medical devices

Selenia® Dimensions®/ 3Dimensions™ Mammography System

Issued September 6, 2024
Issue
After the release of the dimensions system software version 1.12.0/2.3.0 kits to the field, several users reported that c-view images were displaying a blurriness and lack of sharpness versus clear c-view images of the 1.11/2.2 release. Recall start date: August 19, 2024
Hazard description
Performance
Product
Product name
Selenia® Dimensions®/ 3Dimensions™ Mammography System
Reference
ID
RA-76008