Health product recall

Selenia® Dimensions®/ 3Dimensions™ Mammography System

Brand(s)
Last updated

Summary

Product
Selenia® Dimensions®/ 3Dimensions™ Mammography 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

Selenia® Dimensions®/ 3Dimensions™ Mammography System

Software version 1.12.0/2.3.0

3DM-SYS-INTL3D

Issue

After the release of the dimensions system software version 1.12.0/2.3.0 kits to the field, several users reported that c-view images were displaying a blurriness and lack of sharpness versus clear c-view images of the 1.11/2.2 release.

Recall start date: August 19, 2024

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-76008

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