Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size
Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could lead to incorrect radiation treatment delivery, posing a risk of significant injury.
Plain-English summary
Elekta, Inc. is recalling the MOSAIQ Oncology Information System, a software system used to manage workflows for treatment planning and delivery in radiotherapy and chemotherapy. The recall affects software version 2.41 and higher.
The recall is being issued because a problem exists in the software that results in the incorrect field size being sent to the treatment machine for stereotactic plans using cones. This defect could impact the accuracy of radiation treatment delivery.
The recall involves 74 total units, with 45 located in the United States. The software is distributed worldwide, including in specific US states and internationally to countries such as Austria, Brazil, Canada, and Germany. Healthcare facilities using this software should contact Elekta for further instructions on how to address the issue.
The recalled product
- Product
- MOSAIQ Oncology Information System MOSAIQ is 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.
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 Version 2.41 and higher
Distribution
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