Hologic 3D Mammography Systems Recall: Loose Bolts Risk

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Contact the company & request your remedy

Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Hologic is recalling several models of 3D mammography systems because internal bolts can become loose, missing, or broken over time. This could potentially affect the system's safety and performance during medical imaging.

Why it’s dangerous

Internal bolts in the mammography system can become loose, missing, or broken over time. This could potentially affect the system's safety and performance during medical imaging procedures.

Who’s affected

Healthcare facilities using Hologic 3D mammography systems with the listed model numbers are most at risk. Patients using these systems for breast imaging may also be affected.

How to tell if you have this one

Check the model number on your system, which includes 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-STD-MOB, or 3DM-SYS-STD-NS. The recall includes all serial numbers for these models.

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify your system's model number from the list provided in the recall notice.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

What models are affected?

The affected models include 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-STD-MOB, and 3DM-SYS-STD-NS.

Do I need to do anything?

The recall does not specify a remedy, so no action is required at this time.

Take action

Contact Hologic

We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2168-2026 — Hologic Hologic

Hello,

I own a Hologic that is covered by recall Z-2168-2026 from Hologic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2168-2026 (April 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2168-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D,

Lower-risk recall