Hologic Selenia Dimensions Mammography Systems Recall
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Hologic, Inc. is recalling 4,305 Selenia Dimensions Mammography Systems due to complaints of loose, missing, or broken internal bolts.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States. 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 - FDA 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, fda, Devices.
What Happened
Hologic, Inc. initiated a voluntary recall of Selenia Dimensions Mammography Systems after receiving complaints of systems developing loose, missing, or broken internal bolts over time. The recall is classified as Class II by the FDA and affects units distributed nationwide in the United States.
Which Products Are Affected
The recall covers SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS with the following model numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D. A total of 4,305 units are affected. The recall number is Z-2167-2026.
What You Should Do
Consumers and facilities should follow instructions provided in the firm's notification letter regarding the affected systems.
Why This Matters
The recall involves mammography systems used in medical imaging across the United States, addressing potential mechanical issues identified through customer complaints.
Source
FDA Recall Z-2167-2026 - Hologic, Inc., Marlborough, MA
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA 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 (1,236 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.