3Dimensions ASY-11748-CHDRecalls & reported problems
Hologic, Inc. · Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD. · Class 3
All models of 3Dimensions (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Aug 19, 2024Open, Classified
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
Z-3248-2024 · Root cause: Software design · Recall details · 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-2168-2026 · Apr 8, 2026 · Open, Classified3DIMENSIONS 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-ST
- Z-1144-2023 · Jan 16, 2023 · Open, ClassifiedHologic 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 · TerminatedSelenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Other Digital breast tomosynthesis devices
- 3Dimensions 3DM-SYS-STDHologic, Inc. · Digital breast tomosynthesis1 recall57 reports
- Selenia Dimensions SDM-SYS-6000-3DHologic, Inc. · Digital breast tomosynthesis1 recall29 reports
- Selenia Dimensions SDM-SYS-9000-3DHologic, Inc. · Digital breast tomosynthesis1 recall16 reports
- Selenia Dimensions SDM-SYS-6000-2DHologic, Inc. · Digital breast tomosynthesis1 recall5 reports
- 3Dimensions 3DM-SYS-INTL3DHologic, Inc. · Digital breast tomosynthesis1 recall5 reports
- 3Dimensions 3DM-SYS-INTL2D-MOBHologic, Inc. · Digital breast tomosynthesis1 recall5 reports
- Selenia Dimensions SDA-SYS-3000-2DHologic, Inc. · Digital breast tomosynthesis1 recall4 reports
- Selenia Dimensions SDM-SYS-9000-2DHologic, Inc. · Digital breast tomosynthesis1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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