FUJIFILM Healthcare Americas Corporation is recalling 155 units of various Synapse PACS software versions because the system can produce incorrect diagnostic measurements. This occurs when combining Secondary Capture 2D images lacking pixel spacing data with Breast Tomo Series images. The affected software versions include 7.1.000, 7.1.000US, 7.2.000, 7.2.100, 7.2.200, and 7.3.000. Consumers and healthcare facilities should contact their manufacturer representative immediately to address these software defects.
Incorrect measurements on medical imaging can lead to diagnostic errors, potentially resulting in improper treatment plans or the failure to identify critical medical conditions in patients. While no specific injuries were mentioned, the software defect directly impacts the accuracy of clinical data used for patient care.
Manufacturer initiated recall via letter notification.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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