Z-1271-2024 Class II Ongoing
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
- 35 Units (28 US, 7 OUS)
Product Description
Synapse PACS - Version 7.2.100
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: 7.2.100, UDI: (01)854904006008(10)0702100