Medical devicesUpdated Jan 3, 2026Gyrus Acmi, IncOfficial source

    Soltive Laser System recall in Canada: Device compatibility issues

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    In plain language

    This recall involves the Soltive Laser System, including the Soltive Premium Superpulsed Laser System, Soltive Wired Footswitch, and Soltive Wireless Footswitch. It's being recalled because of device compatibility and performance issues, specifically with the wireless footswitch pairing. Healthcare professionals should ensure a wired footswitch is available as a backup.

    What to do

    • Contact the manufacturer if you require additional information.
    • Ensure a wired footswitch is available for immediate use as a backup.

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    Affected products

    • Soltive Premium Superpulsed Laser System

      Model: TFL-PLS

      Lot: All lots.

    • Soltive Wired Footswitch

      Model: TFL-AFSW

      Lot: All lots.

    • Soltive Wireless Footswitch

      Model: TFL-AFSWL

      Lot: All lots.

    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: All lots.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: TFL-AFSW, TFL-AFSWL, TFL-PLS

    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 Soltive Laser System, including the Soltive Premium Superpulsed Laser System, Soltive Wired Footswitch, and Soltive Wireless Footswitch. It's being recalled because of device compatibility and performance issues, specifically with the wireless footswitch pairing. Healthcare professionals should ensure a wired footswitch is available as a backup.

    What should consumers do?

    Contact the manufacturer if you require additional information. Ensure a wired footswitch is available for immediate use as a backup.

    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 12, 2024.

    Is the Gyrus Acmi, Inc brand affected by this recall?

    Yes, Gyrus Acmi, Inc products are affected by this recall. This recall involves the Soltive Laser System, including the Soltive Premium Superpulsed Laser System, Soltive Wired Footswitch, and Soltive Wireless Footswitch. It's being recalled because of device compatibility and performance issues, specifically with the wireless footswitch pairing. Healthcare professionals should ensure a wired footswitch is available as a backup.