Elekta Focal Sim radiation therapy system recalled for image statistics error
Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.
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 used for radiation therapy planning where an error could lead to incorrect treatment dosing. While no injuries are reported, the potential for harm from incorrect radiation planning places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 907 units of the Focal Sim radiation therapy treatment planning system, specifically Focal Release 4.80. The recall is due to a defect in the Monaco Image Statistics Tool, which may result in incorrect CT to ED (Computed Tomography to Electron Density) calculations.
The affected systems were distributed worldwide, including nationwide in the United States and in numerous international locations. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses resulting from this defect.
Healthcare facilities and users of the Focal Sim system should contact Elekta, Inc. for further instructions on how to address the issue with the Monaco Image Statistics Tool. Consumers should not use the affected software for treatment planning until the issue is resolved or a fix is provided by the manufacturer.
The recalled product
- Product
- Focal Sim radiation therapy treatment planning system
- Manufacturer
- Elekta, Inc.
- Affected units
- 907
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)
- Focal Release 4.80
Distribution
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