C-RAD POSITIONING AB is recalling Catalyst software (version c4D 6.5.1 SP2) used with radiotherapy positioning devices, affecting approximately 44 units worldwide. A software defect can prevent the scanning equipment from applying the correct field rotation during patient positioning. While no injuries or incidents have been reported, using the affected software could lead to incorrect patient alignment during radiotherapy treatments. This recall covers several models in the Catalyst and Catalyst+ product lines.
The software failure causes incorrect field rotation to be applied during radiotherapy positioning. This defect may result in the radiation beam being misaligned with the patient's anatomy, potentially leading to treatment errors or unintended radiation exposure to healthy tissue.
Firm initiated software correction
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
Software issue with scanning equipment resulting in incorrect field rotation.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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