Elekta, Inc. is recalling 64 units of its MOSAIQ Oncology Information System software due to a calculation error. Specific versions of the software may calculate incorrect image offsets when used with Linear Accelerators (LINACs) that are not characterized at the IEC61217 scale. This error affects patient positioning data used during radiation therapy. To date, no injuries have been reported in connection with this issue.
Incorrect image offset calculations can lead to radiation being delivered to the wrong part of a patient's body. This poses a risk of serious injury from radiation overdose to healthy tissue or reduced treatment effectiveness if the tumor is not accurately targeted.
Affects LINACs not characterized at IEC61217 scale.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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