Health Canada — Medical Devices · Canada · 2024-08-30 · Type II
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Reported risk: GE Healthcare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. In an unlikely scenario that the partial study is unnoticed, it can lead to misdiagnosis. Centricity PACS is able to uniquely identify approximately 2.1 billion images (e.g. equivalent to 21 million exams with 100 images each). However, there is no notification to the user when the maximum number of unique image identifiers has been reached. Recall Start Date: August 22, 2024
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