FDA DevicesClass II
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning ...
Published: February 18, 2026Recall ID: Z-1339-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98212 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| Address 2 | N/A |
| Code info | Lot Code: 07340048311236 (LGP 11.1) |
| Postal code | 30346-1227 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | N/A |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251212 |
| Initial firm notification | Letter |
| Center classification date | 20260210 |
Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.