Elekta Monaco RTP System Software Recall for Contour Deletion Error
Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.
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 involves a medical device software defect that could lead to incorrect treatment plans (risk of harm), but the source text does not report any specific injuries, illnesses, or FDA Class I classification, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling the Monaco RTP System, a software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall affects 3,012 units of Software 3.1 and higher, which were distributed worldwide to numerous countries and U.S. states.
The recall is issued because of a specific software defect. In a workflow where contours are edited (enlarged, moved, or copied) and then deleted on some slices before being saved in the same session, the deleted contours may still be present in the final plan. This outcome contradicts the intent of the planner, potentially leading to inaccurate treatment planning.
Healthcare providers using this software should be aware of this defect. The source text does not specify specific corrective actions or consumer instructions beyond the identification of the affected software version and the nature of the error.
The recalled product
- Product
- Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 3,012
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 3.1 and higher.
Distribution
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