Elekta, Inc. Recall: Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment
Elekta, Inc. Recall: Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Elekta, Inc.; Product: Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product D
| Recalling firm | Elekta, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | 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, Chin |
| Recall initiated | 20251212 |
| Recall number | Z-1340-2026 |
| Category | device |
| State | GA |
| Country | United States |
$29/mo
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