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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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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