SOLTIVE™ Premium SuperPulsed Laser System recall in Canada: incorrect settings
In plain language
This recall involves the SOLTIVE™ Premium SuperPulsed Laser System sold in Canada. It's being recalled because an incorrect translation in the user interface could lead to wrong laser settings. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer for additional information.
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Affected products
SOLTIVE™ Premium SuperPulsed Laser System
Model: TFL-PLS
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Incorrect energy delivery to patient's anatomy
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 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.
Frequently Asked Questions
Why was this product recalled?
Incorrect energy delivery to patient's anatomy
What should consumers do?
Contact the manufacturer for 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?
Yes, there may be a health risk. Incorrect energy delivery to patient's anatomy
When was this product recalled?
This product was recalled on September 25, 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™ Premium SuperPulsed Laser System sold in Canada. It's being recalled because an incorrect translation in the user interface could lead to wrong laser settings. Healthcare professionals should contact the manufacturer for more information.