FDAOctober 10, 2024device
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.
What to do
FDA enforcement status: Ongoing
Brands named
philips medical systems technologiesphilipsphilips medical
UPCs
00884838100350
Recall history
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