Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors
Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from incorrect radiation dosing.
Plain-English summary
Elekta, Inc. is recalling 154 units of Monaco Radiation Treatment Planning software, version 5.10.01. This software is used to create treatment plans for patients prescribed external beam radiation therapy. The recall was initiated because of a defect that caused unintended updates to Dose and MU (Monitor Unit) values and incorrect assignment of bolus.
The affected software was distributed in California, Indiana, Michigan, Missouri, Texas, and Wisconsin, as well as in Australia, Canada, Germany, Greece, India, the Netherlands, New Zealand, Turkey, and the United Kingdom. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities using this software should contact Elekta, Inc. for instructions on how to address the defect and ensure patient safety. Patients who have received treatment using this software should consult their healthcare provider if they have concerns about their treatment plan.
The recalled product
- Product
- Monaco - Radiation Treatment Planning 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 5.10.01
Distribution
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