FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.1.000

Recalled March 13, 2024 · FDA recall Z-1268-2024 · 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

22 units (22 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 7.1.000

Manufacturer(s)

FUJIFILM Healthcare Americas Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →