Elekta
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Elekta and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-17FDA-DeviceClass IIElekta MOSAIQ cancer treatment software may fail to load plans
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- 2026-03-25FDA-DeviceClass IICheck your Leksell Gamma Knife serial number
Due to adapter not being properly aligned or locked in place.
- 2026-02-18FDA-DeviceClass IIContact Elekta about Leksell GammaPlan software update
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.
- 2026-02-18FDA-DeviceClass IICheck Elekta Leksell GammaPlan treatment plans
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.
- 2026-02-04FDA-DeviceClass IICheck your Elekta radiation therapy system
Due to a manufacturing issue and electrical grounding of systems.
- 2026-01-21FDA-DeviceClass IICheck Elekta MOSAIQ particle therapy software
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
- 2025-11-26FDA-DeviceClass IIMOSAIQ 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.
- 2025-11-12FDA-DeviceClass IIBrand 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
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