RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Hologic, Inc.Official source

    2D/3D Mammography Systems recall in Canada: performance issue

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    In plain language

    This recall involves Hologic 2D/3D Mammography Systems used in healthcare settings in Canada. They are being recalled because a hardware component failure could cause unexpected movement of the c-arm. Healthcare facilities should contact the manufacturer for more information.

    What to do

    • Contact the manufacturer, Hologic, Inc., for additional information.
    • Report any health or safety concerns.

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    Affected products

    • Selenia Dimensions 2d/3d Mammography System-2d Main Unit

      Model: 81003121439

      Lot: 81003121439

    • 3dimensions Mammography System

      Model: 3DM160700423

      Lot: 3DM160700423

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: 3DM160700423, 81003121439

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 3DM160700423, 81003121439

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    This recall involves Hologic 2D/3D Mammography Systems used in healthcare settings in Canada. They are being recalled because a hardware component failure could cause unexpected movement of the c-arm. Healthcare facilities should contact the manufacturer for more information.

    What should consumers do?

    Contact the manufacturer, Hologic, Inc., for additional information. Report any health or safety concerns.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on February 7, 2023.

    Is the Hologic, Inc. brand affected by this recall?

    Yes, Hologic, Inc. products are affected by this recall. This recall involves Hologic 2D/3D Mammography Systems used in healthcare settings in Canada. They are being recalled because a hardware component failure could cause unexpected movement of the c-arm. Healthcare facilities should contact the manufacturer for more information.