FDA Enforcement
Class II
Ongoing
Synapse PACS - Version 7.2.100
Recall: Z-1271-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1271-2024
- 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 7.2.100
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: 7.2.100, UDI: (01)854904006008(10)0702100
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
35 Units (28 US, 7 OUS)