Official recall record
Affirm® Prone Breast Biopsy System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-30
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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