FDA recall Z-1272-2024

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

Synapse PACS - Version 7.2.200

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.

Key facts

Status
Ongoing
Initiation date
2024-01-10
Report date
2024-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2024