Recall Monitor
Health Products

Affirm® Prone Breast Biopsy System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Affirm® Prone Breast Biopsy System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Affirm® Prone Breast Biopsy SystemMore than 10 numbers, contact manufacturer.PBX-SYS-AFFIRM-2D
Affirm® Prone Breast Biopsy SystemMore than 10 numbers, contact manufacturer.PBX-SYS-AFFIRM-3D

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

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