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Selenia Dimensions 2D/3D Mammography Systems

Issued April 22, 2026
Issue
Product Selenia Dimensions 2D/3D Mammography Systems Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
Hologic is initiating this voluntary field safety corrective action because the vertical travel assembly on 3Dimensions and Selenia Dimensions systems may experience internal bolt failure over time. The vertical travel assembly contains eight internal bolts that secure the c-arm to the assembly. Devices with loose, missing or broken bolts may exhibit shaking, vibration or uncommanded c-arm motion.
Reference
ID
RA-82194