Medical Device Recall: Synapse PACS - Version 7.1.000US
FUJIFILM Healthcare Americas Corporation · January 10, 2024
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
3 Units (3 US)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1269-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.