Recall archive / FDA device enforcement
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is t... — FDA record Z-0497-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Philips Medical Systems Technologies Ltd.
- Quantity
- 2439 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0497-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (01)00884838100350(11)200221(10)12.2.5; (01)00884838100350(11)200812(10)12.2.6.0; (01)00884838100350(11)201207(10)12.2.6.100; (01)00884838100350(11)210303(10)12.2.6.200; (01)00884838100350(11)210518(10)12.2.6.201; (01)00884838100350(11)210729(10)12.2.6.300; (01)00884838100350(11)210502(10)12.2.8.0; (01)00884838100350(11)220112(10)12.2.8.100; (01)00884838100350(11)221213(10)12.2.8.200; (01)00884838100350(11)230301(10)12.2.8.210; (01)00884838100350(11)230320(10)12.2.8.300; (01)00884838100350(11)230608(10)12.2.8.310; (01)00884838100350(11)230718(10)12.2.8.400; (01)00884838100350(11)230810(10)12.2.8.401; (01)00884838100350(11)230824(10)12.2.8.317; (01)00884838100350(11)231019(10)12.2.8.412; (01)00884838100350(11)231108(10)12.2.8.403; (01)00884838100350(11)231129(10)12.2.8.413; (01)00884838100350(11)231214(10)12.2.8.414; (01)00884838100350(11)231204(10)12.2.8.420; (01)00884838100350(11)240101(10)12.2.8.415; (01)00884838100350(11)240116(10)12.2.8.421; (01)00884838100350(11)240204(10)12.2.8.422; (01)00884838100350(11)240226(10)12.2.8.424; (01)00884838100350(11)240311(10)12.2.8.426; (01)00884838100350(11)240407(10)12.2.8.440; (01)00884838100350(11)240425(10)12.2.8.450; (01)00884838100350(11)240613(10)12.2.8.451; (01)00884838100350(11)240715(10)12.2.8.452; (01)00884838100350(11)240715(10)12.2.8.454; (01)00884838100350(11)230926(10)12.2.8.410 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide and Worldwide Distribution Foreign: Country Argentina Australia Austria Belgium Brazil Chile China Colombia Denmark Finland France Germany Gibraltar Greece Guernsey Holy See (Vatican City State) Hong Kong Hungary Indonesia Ireland Israel Italy Japan Jersey Jordan Lebanon Malaysia Mexico Netherlands New Zealand Norway Oman Panama Philippines Poland Portugal Romania Saudi Arabia Serbia Slovenia Spain Sweden Switzerland Taiwan Thailand United Kingdom
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 10, 2024
- Center classification date
- Nov 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.