Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors
Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.
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 involves a medical device defect that could result in patients receiving higher radiation doses than prescribed, posing a significant risk of injury. This aligns with the rubric criterion for 'significant injury' reports or high-risk device defects.
Plain-English summary
Elekta, Inc. is recalling MOSAIQ Oncology Information Systems and Sequencers. The recall involves 3,950 units total, with 1,747 units distributed in the United States. The affected software includes MOSAIQ Radiation Oncology version 1.0 and higher and Multi-ACCESS version 6.1 and higher.
The recall is due to a potential software defect where Wedge IDs may not be included in the DICOM RT PLAN sent from the Treatment Planning System (TPS). If this occurs, the treatment field in MOSAIQ is created without the planned wedge. Treating a field without the planned wedge results in the patient receiving more radiation dose than the treatment plan indicates.
The affected units were distributed nationwide to healthcare facilities in all 50 states, the District of Columbia, and Puerto Rico. Healthcare facilities using these systems should contact Elekta for further instructions on how to address the potential data integrity issue.
The recalled product
- Product
- MOSAIQ¿ Oncology Information System and Sequencer 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…
- Manufacturer
- Elekta, Inc.
Distribution
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