Health Canada10 Jun 2026
Selenia Dimensions 2D/3D Mammography Systems
Health Canada published a recall notice for Selenia Dimensions 2D/3D Mammography Systems on 10 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 10 Jun 2026
- Recall type
- Health product recall
- Companies
- Hologic, Inc.600 Technology Drive, Newark, Delaware, United States, 19702
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-06-10 Affected products: Affected products Lot or serial number Model or catalogue number Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-SYS-6000-3D-V19 Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-00001-3D Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-SYS-9000-3D Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-05000-3D3 Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-05000-3DC Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-05000-3D2 Selenia Dimensions 2D/3D Mammography System - 3D Main Unit More than 10 numbers, contact manufacturer. SDM-SYS-9000-3D-V19
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.