Synapse PACS medical imaging software version 7.1.000 recalled for measurement error
Synapse PACS Version 7.1.000 medical imaging software produces incorrect measurements when Secondary Capture 2D images without pixel spacing are combined with Breast Tomo Series data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported hospitalizations or adverse events, but the defect involves incorrect measurements in medical imaging software that could affect diagnostic accuracy. Per the severity rubric, it qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synapse PACS Version 7.1.000, a medical imaging software system used for picture archiving and communication, is being recalled by FUJIFILM Healthcare Americas Corporation due to a measurement accuracy defect.
The software produces incorrect measurements when Secondary Capture 2D images lacking pixel spacing information in their DICOM header are combined with Breast Tomo Series imaging data. This defect could result in inaccurate diagnostic measurements in breast imaging.
The recalled software has been distributed worldwide to 22 units, including distribution to healthcare facilities throughout the United States, Puerto Rico, Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, United Arab Emirates, and the United Kingdom.
Healthcare providers currently using this software version should contact FUJIFILM Healthcare Americas Corporation for remediation options and guidance on addressing the measurement inaccuracy in the specific imaging scenario described.
The recalled product
- Product
- Synapse PACS - Version 7.1.000
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- measurement-inaccuracy
- breast-imaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Version: 7.1.000
- UDI: (01)854904006008(10)0701000
Distribution
Distributed nationwide across the United States.
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