RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026ACUSONOfficial source

    ACUSON SC2000 recall in Canada: May cause patient misdiagnosis

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    In plain language

    This recall involves the ACUSON SC2000 ultrasound system sold in Canada. It's being recalled because a software issue may lead to incorrect patient diagnosis. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Return, repair, or dispose of it as instructed.

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    Affected products

    • ACUSON SC2000

      Model: 10433816

    Why this matters

    Patient misdiagnosis

    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 model number

      Model numbers are typically on the product label or packaging.

      Affected models: 10433816

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Patient misdiagnosis

    What should consumers do?

    Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.

    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?

    Yes, there may be a health risk. Patient misdiagnosis

    When was this product recalled?

    This product was recalled on November 22, 2019.

    Is the ACUSON brand affected by this recall?

    Yes, ACUSON products are affected by this recall. This recall involves the ACUSON SC2000 ultrasound system sold in Canada. It's being recalled because a software issue may lead to incorrect patient diagnosis. Stop using the product and follow the return/repair steps in the official notice.