Selenia Dimensions Mammography Systems Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Hologic is initiating a voluntary field safety corrective action for Selenia Dimensions 2D/3D Mammography Systems due to potential internal bolt failure.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on June 26, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, medical-devices.
What Happened
Hologic, Inc. is initiating a 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.
Which Products Are Affected
The following Selenia Dimensions 2D/3D Mammography System - 3D Main Unit models are affected, with more than 10 serial numbers for each (contact manufacturer for details):
- SDM-SYS-6000-3D-V19
- SDM-00001-3D
- SDM-SYS-9000-3D
- SDM-05000-3D3
- SDM-05000-3DC
- SDM-05000-3D2
- SDM-SYS-9000-3D-V19
What You Should Do
Contact the manufacturer for additional information regarding the field safety corrective action.
Why This Matters
Devices with loose, missing or broken bolts may exhibit shaking, vibration or uncommanded c-arm motion.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,117 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 26, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.