FDAFDA · Food and drugs·Recall number Z-1273-2024
Synapse PACS - Version 7.3.000
Published March 13, 2024 · Recall initiated: January 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Distributor
- 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.
- Lot
- Software Version: 7.3.000, UDI: (01)854904006008(10)0703000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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