Medical devicesUpdated Jan 3, 2026Acutronic Medical Systems AgOfficial source

    Fabian Ventilators recall in Canada: labelling and packaging issue

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    In plain language

    This recall involves Fabian Ventilators sold in Canada. They are being recalled because of an issue with labelling and packaging. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • Fabian Therapy Evolution Software version 5.2.2

      Lot: 121001

    • Fabian Hfo Premature Infant And Paediatric Ventilator - Ventilator Software version 5.2.2

      Lot: 111001, 111001.01, 112001, 113001

    • Fabian +Ncpap Evolution Software version 5.2.2

      Lot: 122001

    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: 111001, 111001.01, 112001, 113001, 121001, 122001

    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 Fabian Ventilators sold in Canada. They are being recalled because of an issue with labelling and packaging. Contact the manufacturer for more information.

    What should consumers do?

    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 July 10, 2024.

    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 Fabian Ventilators sold in Canada. They are being recalled because of an issue with labelling and packaging. Contact the manufacturer for more information.