Medical devicesUpdated Jan 3, 2026Agfa Healthcare N.V.Official source

    Enterprise Imaging XERO Viewer recall in Canada: performance issue

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    In plain language

    This recall involves the Enterprise Imaging XERO Viewer, all versions 8.X, sold in Canada. It's being recalled because of a performance issue related to 3D volume orientation. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer if you require additional information.

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    Affected products

    • Enterprise Imaging XERO Viewer

      Lot: All Versions 8.X

    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: All Versions 8.X

    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 the Enterprise Imaging XERO Viewer, all versions 8.X, sold in Canada. It's being recalled because of a performance issue related to 3D volume orientation. Stop using the product and contact the manufacturer for more information.

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer if you require additional information.

    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 September 18, 2024.

    Is the Agfa Healthcare N.V. brand affected by this recall?

    Yes, Agfa Healthcare N.V. products are affected by this recall. This recall involves the Enterprise Imaging XERO Viewer, all versions 8.X, sold in Canada. It's being recalled because of a performance issue related to 3D volume orientation. Stop using the product and contact the manufacturer for more information.