United StatesLeksell GammaPlan radionuclide radiation therapy treatment‑planning software (software versions 11.1, 11.3, and 11.4; Lot Codes: 07340048311236 for LGP 11.1, 07340048311878 for LGP 11.3, and 07340201502136 for LGP 11.4) is affected. The software was recalled because an error when defining a new stereotactic reference—if users do not first change an already defined obsolete reference to a pre‑plan reference—may produce a treatment plan that could irradiate the incorrect patient location if the error is not detected by users.
What's being recalled
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Recalling firm: Elekta, Inc., Atlanta, GA, United States.
How to identify it
Lot Code: 07340048311236 (LGP 11.1) Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)