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Health Canada Medical devices

Affirm® Prone Breast Biopsy System

Issued July 30, 2025
Issue
Hologic Inc. recently discovered that the Affirm® Prone Breast Biopsy System is exhibiting a slightly elevated level of radiation to the side of the breast platform below the table. This radiation is only present when exposures are performed. Recall start date: July 7, 2025
Hazard description
Performance
Product
Product name
Affirm® Prone Breast Biopsy System
Reference
ID
RA-77787