Elekta recalls
11 federal recalls on file, showing the 7 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Elekta and put it in plain English.
Recent recalls
Elekta MOSAIQ cancer treatment software may fail to load plansElekta's MOSAIQ Oncology Information System software (version 3.2) may fail to load an adapted baseline shift plan during cancer treatment delivery if a communication error occurs. This could affect the accuracy of radiation therapy positioning. No injuries have been reported.
ModerateFDAJun 17, 2026
- Check your Leksell Gamma Knife serial number
Elekta has recalled certain Leksell Gamma Knife Perfexion and Icon radiosurgery systems because an adapter component may not be properly aligned or locked in place. This could affect the accuracy of radiation delivery during treatment. No injuries have been reported.
ModerateFDAMar 25, 2026
- Check Elekta Leksell GammaPlan treatment plans
Elekta's Leksell GammaPlan software version 11.1 has a bug that can cause incorrect radiation targeting during Gamma Knife treatment planning. If users don't update an old reference point before creating a new treatment plan, the radiation may be aimed at the wrong location. This error may not be caught during normal review.
SeriousFDAFeb 18, 20262 products
- Check your Elekta radiation therapy system
Elekta medical linear accelerators used in cancer radiation therapy have a manufacturing defect affecting electrical grounding in certain models and lot codes. The issue could potentially affect the safe operation of these systems. No injuries have been reported to date.
ModerateFDAFeb 4, 2026
- Check Elekta MOSAIQ particle therapy software
Certain versions of Elekta's MOSAIQ oncology information system may deliver twice the intended radiation dose to cancer patients under specific conditions involving partial treatments and interrupted fields. This could occur when the system fails to verify the correct dose amount after a treatment interruption. The issue affects systems using particle therapy with certain software versions.
SeriousFDAJan 21, 2026
- MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
FDANov 26, 2025
- Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
FDANov 12, 2025