Elekta Monaco RTP System Recalled for Beam Angle Calculation Error
Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.
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 high-risk medical device (radiation treatment planning) where a calculation error could lead to incorrect dosing, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 13 units of the Monaco RTP System, a radiation treatment planning software product. The recall is due to a software defect where the beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
The affected software versions are 3.20.00 and 3.20.01. The units were distributed nationwide, including in the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
Healthcare facilities should contact Elekta, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Monaco RTP System. Radiation treatment planning.
- Manufacturer
- Elekta, Inc.
- Affected units
- 13
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)
- Versions 3.20.00 and 3.20.01
Distribution
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