RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026VolcanoOfficial source

    s5i Imaging System recall in Canada: Interoperability issue

    Share:

    In plain language

    This recall involves the s5i Imaging System sold in Canada. It's being recalled because of an interoperability issue with certain hemodynamic systems. Stop using the product and follow the return/repair steps in the official notice.

    What to do

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

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • s5i Imaging System

      Model: 807400-001

      Lot: Not applicable

    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: Not applicable

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 807400-001

    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?

    This recall involves the s5i Imaging System sold in Canada. It's being recalled because of an interoperability issue with certain hemodynamic systems. Stop using the product and follow the return/repair steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check model 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?

    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 November 28, 2018.

    Is the Volcano brand affected by this recall?

    Yes, Volcano products are affected by this recall. This recall involves the s5i Imaging System sold in Canada. It's being recalled because of an interoperability issue with certain hemodynamic systems. Stop using the product and follow the return/repair steps in the official notice.