Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion
Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.
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 used for radiation therapy where a software defect could lead to incorrect treatment planning. While no specific injuries are reported in the source text, the potential for harm to patients receiving radiation therapy places this in the 'High' category (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Elekta, Inc. is recalling the Monaco radiation therapy treatment planning system, specifically Release 3.30 and higher. The system is used to create treatment plans for patients prescribed external beam radiation therapy, calculating dose for photon and electron plans and displaying dose distributions.
The recall is due to a defect in the Monaco Image Statistics Tool, which may result in incorrect CT to ED (Electron Density) conversions. This error could affect the accuracy of the treatment plans generated by the system.
The recall affects 1,354 units distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. Consumers and healthcare providers should contact Elekta, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Monaco radiation therapy treatment planning 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 and electron treatment plans and displays, on-screen and in…
- Manufacturer
- Elekta, Inc.
- Affected units
- 1,354
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)
- Monaco Release 3.30 and higher
Distribution
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