Elekta MOSAIQ Oncology Software Recalled for Unit Labeling Error
Elekta Impac Software is recalling MOSAIQ oncology software because users may enter metric values into fields labeled with US standard units.
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. The hazard involves a labeling error that could lead to incorrect data entry, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Elekta Impac Software is recalling the MOSAIQ oncology information system, a software product used to manage workflows for treatment planning and delivery. The recall involves 3,732 units distributed worldwide.
The recall was initiated because users may inadvertently enter metric values into Height and Weight fields that are labeled with US Standard Units. This labeling discrepancy could lead to incorrect data entry in the system.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. Users of the affected software versions should refer to the manufacturer for further instructions on how to address the issue.
The recalled product
- Product
- MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
- Manufacturer
- Elekta Impac Software
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3,732
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 (11)
- Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305)
- MOSAIQ 2.20 (00858164002312)
- MOSAIQ 2.30 (00858164002329)
- MOSAIQ 2.40 (00858164002077)
- MOSAIQ 2.41 (00858164002084)
- MOSAIQ 2.60 -2.64 (00858164002091)
- MOSAIQ 2.50 (00858164002107)
- MOSAIQ 2.65 (00858164002220)
- MOSAIQ 2.70 (00858164002037)
- MOSAIQ 2.80 (00858164002251)
- MOSAIQ 2.81 (00858164002282)
Distribution
Distribution scope not specified by the agency.
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