FDA-Device2026-05-20Class IIPROCESSING DEFECT
Hologic 3DIMENSIONS mammography systems recalled for loose or broken internal bolts
What this means
Hologic's 3DIMENSIONS mammography systems may develop loose, missing, or broken internal bolts over time. This affects multiple model variants distributed nationwide. No injuries have been reported.
- If you operate or maintain one of these systems, contact Hologic for inspection and repair instructions
- Do not use an affected system if you suspect loose or broken internal components
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
14837 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2026Want us to check the next one for you?
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