RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Acutronic Medical Systems AgOfficial source

    Fabian HFOi Ventilator recall in Canada: Software defect

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    In plain language

    This recall involves the Fabian HFOi Ventilator sold in Canada. It's being recalled because a software defect may prevent proper bias flow selection for NO system usage. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer for additional information.

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    Affected products

    • Fabian HFOi Ventilator

      Model: 113001, 7200.I

      Lot: More than 10 numbers, contact manufacturer.

    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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 113001, 7200.I

    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 Fabian HFOi Ventilator sold in Canada. It's being recalled because a software defect may prevent proper bias flow selection for NO system usage. Contact the manufacturer for more information.

    What should consumers do?

    Contact the manufacturer for 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 April 12, 2022.

    Is the Acutronic Medical Systems Ag brand affected by this recall?

    Yes, Acutronic Medical Systems Ag products are affected by this recall. This recall involves the Fabian HFOi Ventilator sold in Canada. It's being recalled because a software defect may prevent proper bias flow selection for NO system usage. Contact the manufacturer for more information.