FDA Enforcement
Class II
Ongoing
Synapse PACS - Version 7.1.000US
Recall: Z-1269-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1269-2024
- Event ID
- 94090
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- FUJIFILM Healthcare Americas Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2024
- Initiation Date
- January 10, 2024
- Classification Date
- March 7, 2024
- Address
- 81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States
Description
Synapse PACS - Version 7.1.000US
Reason
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.
Code Info
Software Version: 7.1.000US, UDI: (01)854904006008(10)0701000US
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.
Quantity
3 Units (3 US)