Medical devicesUpdated Jan 3, 2026Pinnacle³Official source

    Pinnacle³ Radiation Therapy Planning System recall in Canada: performance issue

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    In plain language

    This recall involves the Pinnacle³ Radiation Therapy Planning System sold in Canada. It's being recalled because a software issue could lead to incorrect radiation doses. Healthcare professionals should contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • Pinnacle³ 16.2.1

      Model: 459801419352, 459801421292

      Lot: Not applicable.

    • Pinnacle Therapy Planning System - Syst

      Model: 459801566249

      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: 459801419352, 459801421292, 459801566249

    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 Pinnacle³ Radiation Therapy Planning System sold in Canada. It's being recalled because a software issue could lead to incorrect radiation doses. Healthcare professionals should 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 August 19, 2025.

    Is the Pinnacle³ brand affected by this recall?

    Yes, Pinnacle³ products are affected by this recall. This recall involves the Pinnacle³ Radiation Therapy Planning System sold in Canada. It's being recalled because a software issue could lead to incorrect radiation doses. Healthcare professionals should contact the manufacturer for more information.