FDA-Device2026-05-20Class IIPROCESSING DEFECT
Hologic Selenia Dimensions mammography systems recalled for loose or broken internal bolts
What this means
Hologic has recalled multiple models of Selenia Dimensions mammography systems because internal bolts can become loose, missing, or broken over time. This may affect the system's structural integrity or function. No injuries have been reported.
- If your facility operates one of the affected Selenia Dimensions models, contact Hologic immediately for inspection and repair instructions.
- Do not use the system if bolts are found to be loose or broken until it has been serviced by Hologic.
The agency's original wording
Hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
4,305 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2026Want us to check the next one for you?
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