Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves incorrect dose calculations for radiation therapy, which poses a significant risk of patient injury if treatment plans are not corrected.
Plain-English summary
Elekta, Inc. is recalling 154 units of the Monaco Radiation Treatment Planning System, specifically software version 5.10.00. This medical device is used to create treatment plans for patients prescribed external beam radiation therapy.
The recall is due to a software defect where dose and Monitor Unit (MU) calculations are incorrect when CT images are viewed from the head and when using multiple prescriptions with forced densities. This error could result in inaccurate treatment plans.
The affected software was distributed worldwide, including in the United States (California, Indiana, Michigan, Missouri, Texas, and Wisconsin) and in Australia, Canada, Germany, Greece, India, the Netherlands, New Zealand, Turkey, and the United Kingdom. Users should contact Elekta for further instructions on how to address the software issue.
The recalled product
- Product
- Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 154
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 Version 5.10.00
Distribution
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