Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error
Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.
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 software defect that could lead to incorrect imaging parameters, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Elekta, Inc. is recalling MOSAIQ Oncology Information System Version 2.64, a software system used to manage workflows for treatment planning and delivery in oncology. The recall involves 551 units distributed in the United States and numerous countries internationally, including Canada, the United Kingdom, and Australia.
The recall is due to a software defect where a Setup field (CT, kV, MV, or MVCT) created by copying a treatment field or another setup field retains the same isocenter as the parent field. This isocenter may not be the correct one for imaging when the data is sent to the machine. The affected software builds are 2.64 SP9 and higher.
Healthcare facilities using this software should contact Elekta for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
- Manufacturer
- Elekta, Inc.
- Affected units
- 551
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)
- Software Build(s): 2.64 SP9 and higher
- UDI (01)00858164002091(10)2.64.235
Distribution
Distribution scope not specified by the agency.
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