Home / Recalls / Medical Devices
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.100
Recalled March 13, 2024 · FDA recall Z-1271-2024 · FUJIFILM Healthcare Americas
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. · FDA Class II
Units
35 Units (28 US, 7 OUS)
Sold at
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.
Description
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.
Product
Synapse PACS - Version 7.2.100
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →