Elekta Recalls MOSAIQ Oncology Information System Software Due to Status Error
Elekta, Inc. is recalling 185 units of MOSAIQ Oncology Information System software because the order status may incorrectly remain 'Approved' when it should indicate 'Complete'.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity software defect.
Plain-English summary
Elekta, Inc. is recalling 185 units of the MOSAIQ Oncology Information System software. The recall involves Software Build(s) 2.64 SP3 and higher. The product was distributed across numerous U.S. states and several international countries, including Australia, Canada, and the United Kingdom.
The recall was initiated because the software exhibits a defect where the order status remains 'Approved' when it should indicate 'Complete'. This error in the oncology information system could potentially impact the tracking of treatment orders.
Healthcare facilities using this software should contact Elekta, Inc. for further instructions on how to address the issue. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Software
- Affected units
- 185
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)
- Software Build(s) 2.64 SP3 and higher
Distribution
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