Philips Medical Systems Technologies Ltd. is recalling approximately 2,439 Vue PACS Diagnostic Viewer systems equipped with Vue PACS client software versions 12.1.5 through 12.2.8.454. A software defect within the Perfusion Application can cause incorrect calculations of brain blood flow maps when exporting results from Siemens CT perfusion studies. This calculation error may lead to incorrect values in maps and tables, potentially causing medical providers to misinterpret diagnostic data. No injuries or incidents have been reported in connection with this issue.
The software error can generate inaccurate ischemic maps and data tables, which may lead to a misdiagnosis or incorrect treatment plan for patients undergoing CT perfusion scans. Inaccurate maps are particularly critical during the evaluation of stroke or other emergency neurological conditions.
Intended for use as a Picture Archiving and Communication System (PACS) in hospitals and related institutions.
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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