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Use caution Medical device recall · FDA · Published April 8, 2026

Hologic SELENIA Dimensions Mammography Systems Recall: Loose Bolts Risk

Hologic recalls SELENIA Dimensions Mammography Systems with model numbers SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, and others due to loose, missing, or broken internal bolts that could affect system stability.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2167-2026Medical deviceHologic ›
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Contact the company

Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020
✎ GovInfoNow plain-language explainer

Hologic is recalling several models of SELENIA Dimensions Mammography Systems because internal bolts can become loose, missing, or broken over time. This could potentially cause the system to become unstable during use, which may lead to injury or equipment damage. Read more at govinfonow.com/recall/49531-hologic-selenia-dimensions-mammography-systems-recall-loose-bolts-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49531-hologic-selenia-dimensions-mammography-systems-recall-loose-bolts-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2167-2026

Cite this page

“Hologic SELENIA Dimensions Mammography Systems Recall: Loose Bolts Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49531-hologic-selenia-dimensions-mammography-systems-recall-loose-bolts-risk. Based on FDA recall #Z-2167-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2167-2026%22&limit=1).

The FDA announced on April 8, 2026, that Hologic, Inc. is recalling Selenia Dimensions Mammography Systems due to loose, missing, or broken internal bolts. The recall affects 4,305 units distributed nationwide.

How to tell if you have it

  • Brand: Hologic
  • Product: Selenia Dimensions Mammography Systems
  • 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
  • Distribution: US Nationwide

The hazard

The FDA stated that complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Context

GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since June 27, 2017. Other recent recalls of similar products include the Philips Azurion System Recall (March 31, 2026), Canon Alphenix X-ray Systems Recall (August 4, 2026), and GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026).

How to tell if you have this one

Check the model numbers on the system: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, and other listed models. The recall includes all units with the specified model numbers and serial numbers.

  • Brand
    Hologic
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2167-2026SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. 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.; "Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.4,305 units
Z-2168-20263DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 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, 3DM-SYS-STD-NS.; "[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.14837 units
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Identify the model number on your SELENIA Dimensions Mammography System to see if it matches the recalled list.

  2. Contact Hologic

    Reach out to Hologic for guidance on next steps, as the recall does not include a specific remedy.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Apr 8, 202612. FDA classified it Class II: May 12, 202623. Published in FDA’s Enforcement Report: May 20, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What models are affected by this recall?

The recall affects SELENIA Dimensions Mammography Systems with 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, and SDM-SYS-9000-3D.

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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-2167-2026 (April 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2167-2026 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA