FUJIFILM Healthcare Americas Corporation: Synapse PACS - Version 7.1.000US

Hazard

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.

Details from the source

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. Quantity: 3 Units (3 US) Lot/code info: Software Version: 7.1.000US, UDI: (01)854904006008(10)0701000US

UPC codes

854904006008

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.