Elekta MOSAIQ software recall for unintended direction selection changes
Elekta, Inc. is recalling MOSAIQ oncology software versions 1.40 through 2.50 because scrolling actions can unintentionally change direction selections.
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 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect involves unintended software behavior that could impact treatment planning workflows, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. The recall covers software versions 1.40 through 2.50, inclusive. The product is used to support information flow among healthcare facility personnel where radiotherapy and/or chemotherapy are prescribed.
The recall is due to a software defect in the Clinical Management Application (CMA). When a user hovers the mouse pointer exactly above the direction dropdowns and uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change. This can occur even when the user's intention was only to move the mouse to a different area of the screen.
The recall affects 723 units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations. Healthcare facilities using the affected software versions should contact Elekta, Inc. for further instructions on resolving the issue.
The recalled product
- Product
- MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 723
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 (2)
- N/A - Software versions 1.40 through 2.50
- inclusive
Distribution
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