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Health Canada Medical devices

Centricity PACS System

Issued August 30, 2024
Issue
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
Hazard description
Performance
Product
Product name
Centricity PACS System
Reference
ID
RA-75994