Elekta Monaco RTP System Recalled for Incorrect Dose Calculation
Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.
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. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Elekta, Inc. is recalling 365 units of the Monaco RTP System, a medical device used to create treatment plans for external beam radiation therapy. The recall covers software builds 5.10 and 5.20. The system is distributed worldwide, including in the United States and numerous international locations.
The recall is due to a software defect that occurs when creating 3D plans using MU or Dose weighting modes. If a user changes the Physician's Intent Rx Dose and/or the number of fractions and then modifies the wedge angle, the MU value is scaled incorrectly. This error affects the calculation of the radiation dose distribution.
Healthcare facilities and users of the Monaco RTP System should contact Elekta for instructions on how to resolve the issue. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distri
- Manufacturer
- Elekta, Inc.
- Affected units
- 365
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)
- Software Builds 5.10 and 5.20
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 · incorrect dose calculation
See all →- HighRayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation
FDA (Devices) · 2023-07-05
- HighRayStation software recall due to incorrect total dose display
FDA (Devices) · 2021-05-26
- HighRayStation Treatment Planning Software Recalled for Dose Calculation Errors
FDA (Devices) · 2020-02-05
- HighElekta Monaco Radiation Treatment Planning System Software Recall
FDA (Devices) · 2019-12-18
- HighElekta Monaco RTP System Recalled for Potential Dose Calculation Errors
FDA (Devices) · 2019-10-02