Elekta Monaco RTP System Recalled for Treatment Planning Error
Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.
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. The hazard involves a software error in a medical device used for radiation therapy planning, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
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 Monaco versions 5.10.00 and higher, with 1,401 units distributed worldwide and across numerous U.S. states.
The recall is due to a software defect that occurs when exporting a 3D Monaco plan with the "Composite Field Sequencing" (CFS) checkbox selected. In this specific scenario, the Y jaws snap to the port shape instead of remaining at their defined positions. This error could result in inaccurate treatment plans for radiation therapy patients.
Healthcare facilities using the affected software should contact Elekta for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 1,401
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)
- Monaco versions 5.10.00 and higher
Distribution
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