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Affirm® prone breast biopsy system

Official notice

30 Jul 2025

Last checked

30 Jul 2025

Medium riskHealth Canada
Watch Hologic

An official Health Canada notice concerns Affirm® prone breast biopsy system. 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 Published 2025-07-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77787

Official notice

2025-07-30

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

77787

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Affected products

Product 1

Affected products - Affirm® Prone Breast Biopsy System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - PBX-SYS-AFFIRM-2D

Product 2

Affected products - Affirm® Prone Breast Biopsy System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - PBX-SYS-AFFIRM-3D

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Hologic, Affirm® Prone Breast Biopsy System

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic, Affirm® Prone Breast Biopsy System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77787

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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