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.
What this means for you
Illness, injury, or structural failure has been reported. 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 a
- Manufacturer
- Elekta, Inc.
Distribution
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