Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure
Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.
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 high-risk medical device software defect that fails to check for drug interactions, posing a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 211 units of the MOSAIQ Oncology Information System, versions prior to 2.60. This software is used to manage workflows for treatment planning and delivery in oncology settings. The recall is due to a defect in the First Databank (FDB) Framework v2.0, a third-party product incorporated into MOSAIQ.
The defect occurs because FDB routinely modifies drugs in its database to reflect market and formulary changes. In FDB Framework v2.0, these modified drugs are not being included in the system's drug-drug, drug-allergy, and duplicate drug therapy interaction checking. This failure means the software may not alert users to potential adverse interactions.
The affected units were distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico. No specific illnesses or injuries have been reported in the source text. Users of the affected software should contact Elekta, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
- Manufacturer
- Elekta, Inc.
- Affected units
- 211
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)
- Versions prior to 2.60.
Distribution
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