Synapse PACS version 7.3.000 produces incorrect breast imaging measurements
FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.
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 recall with no reported illnesses, injuries, or deaths. The hazard is measurement inaccuracy in medical breast imaging software, representing a risk of diagnostic error but with no reported patient harm to date. Per the rubric, this qualifies as 'High' for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synapse PACS (Picture Archiving and Communication System) version 7.3.000, manufactured by FUJIFILM Healthcare Americas Corporation, is being recalled due to a software measurement error. The issue occurs when secondary capture 2D images lacking pixel spacing information in the DICOM header are processed together with breast tomosynthesis series, resulting in incorrect measurements. This error could affect the accuracy of breast imaging analysis.
The recall affects 64 software units (44 in the United States, 20 internationally) distributed worldwide to healthcare facilities in the US, 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 facilities using Synapse PACS version 7.3.000 should contact FUJIFILM Healthcare Americas Corporation to obtain a corrected software version. No illnesses or injuries related to this measurement error have been reported.
The recalled product
- Product
- Synapse PACS - Version 7.3.000
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
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: 7.3.000
- UDI: (01)854904006008(10)0703000
Distribution
Part of a larger recall action
This product is one of 6 recalled by FUJIFILM Healthcare Americas Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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