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Elekta, Inc. FDA Recalls
28 recalls on file across devices, 0 of them Class I and 26 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MOSAIQ Oncology Information SystemClass IIMay 21, 2026Software may fail to load adapted baseline shift plan during |
| Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intendedClass IIApr 3, 2026Due to safety concerns regarding the detachment of the tip o |
| Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Class IIApr 3, 2026Due to safety concerns regarding the detachment of the tip o |
| Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitarClass IIApr 3, 2026Due to safety concerns regarding the detachment of the tip o |
| Brand Name: Leksell Vantage Arc System REF: 1053958Class IIMar 19, 2026Locking mechanisms may not properly secure to the Arc syste |
| Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" LekselClass IIFeb 18, 2026Due to adapter not being properly aligned or locked in place |
| Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Class IIDec 14, 2025Due to a manufacturing issue and electrical grounding of sys |
| Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Class IIDec 12, 2025Due to an error when defining a new stereotactic reference t |
| Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 PrClass IIDec 12, 2025Due to an error when defining a new stereotactic reference t |
| MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)Class IIDec 10, 2025Using oncology information system that manages workflow may |
| Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a ProduClass IISep 30, 2025Due to increased risk that paint flakes from the engravings |
| MOSAIQ Oncology Information SystemClass IIJan 15, 2025Image offsets calculated by oncology Information System s |
| ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System AcceleClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System AcClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, LiClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, LinearClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, LinearClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy SClass IIOct 25, 2023Elekta has identified that if the microswitch within the mid |
| Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. ElClass IIMay 5, 2023A component within a limited number of Elekta Linacs has bee |
| Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.Class IIApr 6, 2023There is a low possibility that an electrical connector in t |
| Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapyClass IIFeb 28, 2023Re-optimization, after adding contours without forced densit |
| Oncentra Brachy radiation therapy planning system software.Class IIDec 5, 2022A reconstruction error may occur when using the Catheter Ben |
| Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00Class IIOct 13, 2021Under certain circumstances, there can be a difference betwe |
| Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. ElektClass IISep 17, 2021There is a risk that the Diode D1 in the Modulator can fail |
| Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation Class IISep 14, 2021Contour changes can be saved on an unintended image set. In |
| MOSAIQ Oncology Information SystemClass IISep 2, 2021A drug strength in MOSAIQ can be changed during the ordering |
| Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10Class IIJul 26, 2021If a couch is removed while a plan is loaded, and then added |
| Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic CloudClass IIApr 20, 2021Malware attack |