RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026SignaOfficial source

    Signa MRI Systems recall in Canada: thermal dose and localized heating risk

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    This recall involves the Signa HDe 1.5T MRI System and Signa Explorer sold in Canada. They are being recalled because incorrect software could lead to higher than expected thermal doses and localized heating for patients. Stop using the product and follow the return/repair steps in the official notice.

    What to do

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

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    Affected products

    • Signa HDe 1.5T MRI System

      Model: S7505KY

      Lot: 00000008704YR9, 00000009948YR1, 00000010023YR0, 00000010685YR6, 00000010833YR2, 00000011827YR3

    • Signa Explorer

      Model: 6433266-1

      Lot: 3793TA7

    Why this matters

    Higher than expected thermal dose and localized heating to the patient

    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: 00000008704YR9, 00000009948YR1, 00000010023YR0, 00000010685YR6, 00000010833YR2, 00000011827YR3, 3793TA7

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 6433266-1, S7505KY

    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?

    Higher than expected thermal dose and localized heating to the patient

    What should consumers do?

    Stop using the product immediately. Check model and serial numbers. 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. Higher than expected thermal dose and localized heating to the patient

    When was this product recalled?

    This product was recalled on November 30, 2018.

    Is the Signa brand affected by this recall?

    Yes, Signa products are affected by this recall. This recall involves the Signa HDe 1.5T MRI System and Signa Explorer sold in Canada. They are being recalled because incorrect software could lead to higher than expected thermal doses and localized heating for patients. Stop using the product and follow the return/repair steps in the official notice.