Z-1273-2024 Class II Ongoing
FDA device recall Z-1273-2024 was initiated by FUJIFILM Healthcare Americas Corporation on January 10, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 64 Units (44 US, 20 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2024
- Initiation Date
- January 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 Units (44 US, 20 OUS)
Product Description
Synapse PACS - Version 7.3.000
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 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.
Code Information
Software Version: 7.3.000, UDI: (01)854904006008(10)0703000