Medical Device Imaging Software May Calculate Incorrect Breast Measurements
Synapse PACS Version 7.1.000US may produce incorrect measurements when Secondary Capture 2D images lack pixel spacing information in the DICOM header. The affected software is installed in healthcare facilities worldwide, including the United States and Puerto Rico.
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 involving diagnostic imaging software. Although no illnesses or injuries have been reported, measurement inaccuracies in medical imaging represent a risk-of-harm scenario where incorrect diagnostic information could influence patient care decisions.
Plain-English summary
FUJIFILM Healthcare Americas Corporation has recalled Synapse PACS Version 7.1.000US, a software system installed in healthcare facilities worldwide. The recall affects 3 units, with distribution including the United States, Puerto Rico, and 18 other countries.
The software produces incorrect measurements when Secondary Capture 2D images that lack pixel spacing information in the DICOM header are combined with Breast Tomo Series images. This measurement error could impact diagnostic interpretation of breast imaging studies.
Healthcare facilities using this software version should manually verify all measurements before clinical use. The FDA classified this as a Class II recall. Healthcare providers should contact FUJIFILM Healthcare Americas Corporation for guidance on remediation.
The recalled product
- Product
- Synapse PACS - Version 7.1.000US
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- measurement-error
- diagnostic-imaging-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: 7.1.000US
- UDI: (01)854904006008(10)0701000US
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27