FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2024 - (Recall #: Z-1272-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Synapse PACS - Version 7.2.200

Product Classification:

Class II

Date Initiated: January 10, 2024

Date Posted: March 13, 2024

Recall Number: Z-1272-2024

Event ID: 94090

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.

Status: Ongoing

Product Quantity: 12 Units (12 US)

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.

Voluntary or Mandated:

Voluntary: Firm initiated