FUJIFILM Synapse PACS Software Produces Incorrect Breast Imaging Measurements
FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.
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 software that produces incorrect measurements in clinical imaging analysis meets the criteria for High severity as a risk-of-harm product where no injuries have been reported.
Plain-English summary
FUJIFILM Healthcare Americas Corporation has recalled Synapse PACS Version 7.2.100, a Picture Archiving and Communication System used by medical facilities worldwide to manage and analyze medical images. Thirty-five units of the software have been distributed globally, including 28 in the United States and 7 internationally across countries including Australia, Brazil, Canada, France, Germany, India, Mexico, Spain, and the United Kingdom.
The software produces incorrect measurements when a Secondary Capture 2D image that lacks pixel spacing information in its DICOM header is combined with a Breast Tomosynthesis Series. This technical condition can result in measurement values that do not accurately reflect the actual dimensions in the imaging data, potentially affecting the accuracy of measurements used in clinical assessment.
Healthcare facilities using Synapse PACS Version 7.2.100 should review their system to determine if they are affected by this condition. Any measurements generated from Secondary Capture 2D images without proper pixel spacing in Breast Tomosynthesis analyses should be verified for accuracy.
FUJIFILM has classified this as a Class II recall and is working with healthcare providers to address the measurement accuracy issue. Facilities with questions should contact FUJIFILM Healthcare Americas Corporation for technical guidance on the affected software version.
The recalled product
- Product
- Synapse PACS - Version 7.2.100
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- incorrect-measurement
- diagnostic-error
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: 7.2.100
- UDI: (01)854904006008(10)0702100
Distribution
Distributed nationwide across the United States.
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