Elekta, Inc. 2026-02-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1340-2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system … Recall
Issued February 18, 2026 · Elekta, Inc.
In February 2026, Elekta, Inc. recalled the Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
What you should do
- 1 Stop using Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Elekta, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Elekta, Inc.
- Category
- Health
- Recall date
- February 18, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM,
- Recall number
- FDA-Z-1340-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Elekta, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.