Elekta Recalls Monaco Radiation Treatment Planning System Software
Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning System devices due to a software defect that may cause incorrect optimization models to be used during online plan adaptation.
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 is classified as FDA Class II, and the defect involves a medical device used for radiation treatment planning, which poses a risk of harm if incorrect optimization models are used, although no specific injuries are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning (RTP) System devices, specifically software version 5.40. The recall is due to a defect where the system may incorrectly reuse a previous optimization model during online plan adaptation of a completion plan.
The issue occurs if the "Improve Target Dose" optimization model was selected in a previous treatment session. In such cases, the software automatically uses this model again when it should not, potentially leading to incorrect treatment planning. The devices were distributed domestically to Wisconsin and Texas, and internationally to Denmark, England, Germany, the Netherlands, and Sweden.
Healthcare facilities using these devices should contact Elekta, Inc. for instructions on how to address the software defect. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Monaco Radiation Treatment Planning (RTP) System
- Manufacturer
- Elekta, Inc.
- Affected units
- 14
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 5.40
Distribution
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