Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software defect regarding file overwriting without reporting any patient injuries, illnesses, or deaths. Per the rubric, this falls under moderate severity as a precautionary recall for a defect that has not resulted in reported harm.
Plain-English summary
Elekta, Inc. is recalling 45 units of the Monaco RTP System, a radiation treatment planning software system. The recall affects software versions 3.10.00 and later. The product was distributed nationwide, including in Alaska, California, Colorado, Connecticut, Florida, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and Puerto Rico.
The recall is due to a defect in the upgrade installation script. The script is designed to overwrite specific pouch files in the Treatment Couch Library with original default values. This action may result in the loss of customized treatment couch data or incorrect default settings being applied during the upgrade process.
Healthcare facilities using the affected software versions should contact Elekta, Inc. for instructions on how to resolve the issue. Users should verify their software version and consult with the manufacturer regarding the impact on their specific treatment planning workflows.
The recalled product
- Product
- Monaco RTP System Radiation treatment planning
- Manufacturer
- Elekta, Inc.
- Affected units
- 45
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)
- Versions 3.10.00 and later
Distribution
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