Affirm® Prone Breast Biopsy System
Brand(s)
Last updated
Summary
Product
Affirm® Prone Breast Biopsy System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Affirm® Prone Breast Biopsy System | More than 10 numbers, contact manufacturer. | PBX-SYS-AFFIRM-2D |
| Affirm® Prone Breast Biopsy System | More 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Hologic, Inc.
600 Technology Drive, Newark, Delaware, United States, 19702
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77787
Get notified
Receive notifications for new and updated recalls and alerts by category.