Reported Nov 27, 2024 · Ongoing
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to…
Philips Medical Systems Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Technologies Ltd. · Matam Building 8/2 · Haifa, N/A · N/A
Is this the product you have?
- Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454
- software Model Number1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites
- Lot codes and dates
31 of 31 products
Products covered by this recall # Barcodes Product as published 1 00884838100350(01)00884838100350(11)200221(10)12.2.5 2 00884838100350(01)00884838100350(11)200812(10)12.2.6.0 3 00884838100350(01)00884838100350(11)201207(10)12.2.6.100 4 00884838100350(01)00884838100350(11)210303(10)12.2.6.200 5 00884838100350(01)00884838100350(11)210518(10)12.2.6.201 6 00884838100350(01)00884838100350(11)210729(10)12.2.6.300 7 00884838100350(01)00884838100350(11)210502(10)12.2.8.0 8 00884838100350(01)00884838100350(11)220112(10)12.2.8.100 9 00884838100350(01)00884838100350(11)221213(10)12.2.8.200 10 00884838100350(01)00884838100350(11)230301(10)12.2.8.210 11 00884838100350(01)00884838100350(11)230320(10)12.2.8.300 12 00884838100350(01)00884838100350(11)230608(10)12.2.8.310 13 00884838100350(01)00884838100350(11)230718(10)12.2.8.400 14 00884838100350(01)00884838100350(11)230810(10)12.2.8.401 15 00884838100350(01)00884838100350(11)230824(10)12.2.8.317 16 00884838100350(01)00884838100350(11)231019(10)12.2.8.412 17 00884838100350(01)00884838100350(11)231108(10)12.2.8.403 18 00884838100350(01)00884838100350(11)231129(10)12.2.8.413 19 00884838100350(01)00884838100350(11)231214(10)12.2.8.414 20 00884838100350(01)00884838100350(11)231204(10)12.2.8.420 - Amount recalled
- 2439 systems
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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