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Health Canada Medical devices

Synapse Picture Archiving And Communications Systems

Issued February 15, 2024
Issue
Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues. Recall start date: January 30, 2024
Hazard description
Performance
Product
Product name
Synapse Picture Archiving And Communications Systems
Reference
ID
RA-75074