Hologic Selenia Dimensions Mammography Systems Recall

Source: FDA · United States

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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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Hologic, Inc. is recalling 4,305 Selenia Dimensions Mammography Systems due to complaints of loose, missing, or broken internal bolts.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.