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3Dimensions 3DM-SYS-INTL3D-MOBRecalls & reported problems

Hologic, Inc. · Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast. · Class 3

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (P080003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 8, 2026Open, Classified

    Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

    Z-2168-2026 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080003. One submission often covers many models, so check the product and lot details in each record.

  • Z-3248-2024 · Aug 19, 2024 · Open, Classified
    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824
  • Z-1144-2023 · Jan 16, 2023 · Open, Classified
    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-
  • Z-1343-2020 · Jan 21, 2020 · Terminated
    Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

Other Digital breast tomosynthesis devices

All Digital breast tomosynthesis devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.