Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging
FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.
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: FDA Class II medical device with a measurement accuracy defect in breast imaging software. The hazard represents risk of harm from incorrect diagnostic measurements—no reported illnesses or injuries to date—meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Synapse PACS Version 7.2.000, a medical imaging software manufactured by FUJIFILM Healthcare Americas Corporation, has been recalled due to a measurement calculation error affecting breast imaging workflows.
The defect occurs when the software processes Secondary Capture 2D images that lack pixel spacing information in the DICOM header while analyzing a Breast Tomo Series. Under these conditions, the software produces incorrect measurements, which could compromise diagnostic accuracy in breast cancer screening and evaluation.
The recall affects 19 units worldwide: 7 in the United States (including Puerto Rico) and 12 distributed internationally in 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.
Affected healthcare facilities should contact FUJIFILM Healthcare Americas Corporation for guidance on remediation options and potential workarounds while a corrected software version is being developed.
The recalled product
- Product
- Synapse PACS - Version 7.2.000
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- measurement-error
- imaging-inaccuracy
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: 7.2.000
- UDI: (01)854904006008(10)0702000
Distribution
Distributed nationwide across the United States.
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