Hologic Inc. is recalling 425 units of Selenia Dimensions and 3Dimensions digital breast tomosynthesis systems due to a software defect. When using system software versions Dimensions 1.12.0 or 3Dimensions 2.3.0 in combination with C-View software, the final synthesized 2D images may appear blurry. This quality issue can lead to a misdiagnosis, specifically the possibility of a false negative result where a medical condition is not identified. Consumers and healthcare facilities using these specific software versions should contact Hologic Inc. or their healthcare provider for further instructions.
The software defect impacts the quality of synthesized 2D images, causing them to appear blurry; this loss of detail may cause a radiologist to miss signs of breast cancer, leading to a false negative diagnosis and delayed treatment.
Manufacturer correction/instruction
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Sources: FDA iRES · Raw API Response
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