Leksell Gamma Knives recall in Canada: performance issue
In plain language
This recall involves Leksell Gamma Knife devices sold in Canada. They are being recalled because a quality assurance procedure failed when an adapter was not properly locked. Healthcare professionals should follow the instructions in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Follow the instructions in the Field Safety Notice.
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Affected products
Leksell Gamma Knife® Perfexion™
Model: 715000
Lot: All lots
Leksell Gamma Knife® Icon™
Model: 1016200
Lot: All lots
Leksell Gamma Knife® Elekta Esprit™
Model: 1110200
Lot: All lots
Why this matters
Medical device performance issue
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1016200, 1110200, 715000
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?
Medical device performance issue
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Follow the instructions in the Field Safety Notice.
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. Medical device performance issue
When was this product recalled?
This product was recalled on February 18, 2026.
Is the Elekta Solutions Ab brand affected by this recall?
Yes, Elekta Solutions Ab products are affected by this recall. This recall involves Leksell Gamma Knife devices sold in Canada. They are being recalled because a quality assurance procedure failed when an adapter was not properly locked. Healthcare professionals should follow the instructions in the official notice.