Philips North America Llc has recalled 96 units of the Big Bore RT, Brilliance CT Big Bore, and Brilliance CT Big Bore Oncology systems equipped with software version V4.8.0.10421. These devices are used in hospitals and oncology centers for radiation therapy planning and diagnostic imaging. A defect in the software's off-set reconstruction feature can cause a shift in the patient's image or provide inaccurate coordinates during treatment planning. This means radiation might be targeted at the wrong location or a patient might receive an incorrect medical diagnosis. Philips has initiated this voluntary recall via letter to affected facilities to address these software inaccuracies.
Incorrect coordinates or image shifts can lead to errors in radiation therapy planning, potentially causing the growth or spread of cancer due to mistargeted treatment. In radiology settings, software errors may result in an inaccurate diagnosis or an improper treatment regimen for the patient.
Manufacturer initiated notification and potential software correction
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.
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Sources: FDA iRES · Raw API Response
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