Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.
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 with a defect that could lead to incorrect treatment planning (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Elekta Inc is recalling the Monaco RTP System, specifically software versions 5.10 and 5.11, which are used as Radiation Treatment Planning Systems. The recall affects 1,396 units distributed worldwide.
The recall is due to a software defect that occurs when creating 3D plans using either MU or Dose weighting modes. If a user changes the number of fractions, rescales the plan, and then changes the wedge angle, the Monitor Units are scaled incorrectly. This error could result in inaccurate treatment planning.
Healthcare facilities and users of the affected software should contact Elekta Inc for further instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Manufacturer
- Elekta Inc
- Affected units
- 1,396
Distribution
Distribution scope not specified by the agency.
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