Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software
Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could impact radiation treatment planning, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 radiation treatment planning software. The software is designed to analyze and plan radiation treatments for patients with cancer. The recall is due to a defect in the planning process where beam weights can be changed and renumbered during dose calculation. In such cases, it is possible to save and reopen the plan without any error messages being displayed.
The affected software was distributed nationwide, including in the states of Alabama, California, the District of Columbia, Kansas, Louisiana, Missouri, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, and Washington. Because the product is software, there are no specific lot codes associated with the recall.
Healthcare facilities using this software should contact Elekta, Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Software
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None as the product is software
Distribution
Related recalls
Same manufacturer · Elekta, Inc.
See all →- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereElekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
- HighMOSAIQ oncology software may fail to load adapted treatment plan
FDA (Devices) · 2026-06-17
- HighLeksell Vantage Arc System locking mechanism may not secure properly
FDA (Devices) · 2026-05-06
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighElekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error
FDA (Devices) · 2016-01-13
- HighElekta Oncentra Brachy software recalled for incorrect dose calculation errors
FDA (Devices) · 2015-06-10
- HighElekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect
FDA (Devices) · 2017-01-18
- SevereElekta Monaco Radiation Treatment Planning System Software Recall
FDA (Devices) · 2015-10-14
- SevereElekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors
FDA (Devices) · 2015-11-04
- SevereElekta XiO RTP System Recalled for Dose Calculation Error
FDA (Devices) · 2014-01-29