Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect
Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.
What this means for you
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 is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect involves a software visualization issue ('horns' in the cross profile) which poses a risk of harm to patients if the planning software is used incorrectly, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling Oncentra External Beam and Oncentra Brachy radiation therapy planning software. The recall was initiated because a cross profile for a Varian 60-degree wedge shows 'horns.' The software is designed to analyze and plan radiation treatment in three dimensions for the purpose of treating patients with cancer.
The recall affects 433 units of the software, covering all software builds. The products were distributed worldwide, including in the United States (AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX) and numerous international countries such as Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The FDA has classified this recall as Class II. Consumers and healthcare providers should contact Elekta, Inc. for further instructions regarding the recall and any necessary software updates or corrections.
The recalled product
- Product
- Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
- Manufacturer
- Elekta, Inc.
- Affected units
- 433
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)
- All software builds
Distribution
Related recalls
Same manufacturer · Elekta, Inc.
See all →- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
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 →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25