RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026PhilipsOfficial source

    Diagnostic Ultrasound Systems recall in Canada: incorrect patient data

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    In plain language

    This recall involves Philips EPIQ and Affiniti Diagnostic Ultrasound Systems used in Canada. They are being recalled because certain workflows could display and save incorrect patient data. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.

    What to do

    • Stop using the affected Diagnostic Ultrasound Systems immediately.
    • Check the model numbers of your systems.
    • Follow the instructions provided by Philips regarding this recall.

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    Affected products

    • EPIQ 5 ULTRASOUND SYSTEM

      Model: EPIQ 5

      Lot: All lots

    • EPIQ 7 ULTRASOUND SYSTEM

      Model: EPIQ 7

      Lot: All lots

    • DIAGNOSTIC ULTRASOUND SYSTEM

      Model: AFFINITI 50, AFFINITI 70

      Lot: All lots

    • AFFINITY 30 DIAGNOSTIC ULTRASOUND SYSTEM

      Model: 989605457591

      Lot: All lots

    • AFFINITY 70 DIAGNOSTIC ULTRASOUND SYSTEM

      Model: AFFINITI 70

      Lot: All lots

    Why this matters

    Incorrect patient data could be displayed and saved

    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 lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 989605457591, AFFINITI 50, AFFINITI 70, EPIQ 5, EPIQ 7

    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?

    Incorrect patient data could be displayed and saved

    What should consumers do?

    Stop using the affected Diagnostic Ultrasound Systems immediately. Check the model numbers of your systems. Follow the instructions provided by Philips regarding this recall.

    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. Incorrect patient data could be displayed and saved

    When was this product recalled?

    This product was recalled on November 20, 2020.

    Is the Philips brand affected by this recall?

    Yes, Philips products are affected by this recall. This recall involves Philips EPIQ and Affiniti Diagnostic Ultrasound Systems used in Canada. They are being recalled because certain workflows could display and save incorrect patient data. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.