Device product
Synapse PACS - Version 7.2.200
Z-1272-2024
Product summary
- Event
- Event 94090
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 Units (12 US)
- Official record key
device-enforcement:Z-1272-2024
Official wording
Reason: 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.
Code information: Software Version: 7.2.200, UDI: (01)854904006008(10)0702200
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.