2D/3D Mammography Systems
Brand(s)
Last updated
Summary
Product
2D/3D Mammography Systems
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Selenia Dimensions 2d/3d Mammography System-2d Main Unit |
81003121439 |
81003121439 |
3dimensions Mammography System |
3DM160700423 |
3DM160700423 |
Issue
Hologic has received a single report of a c-arm performing a significant unexpected movement during non-patient related use of the system. The investigation determined this event was due to a hardware component failure.
Recall start date: January 16, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Hologic, Inc.
36 Apple Ridge Road, Danbury, Connecticut, United States, 06810
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72660
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