Recall Z-0497-2025 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems Technologies Ltd.
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.
| Date | Nov 20, 2024 (initiated Oct 10, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Philips issued URGENT Medical Device Correction letter(# 2024-EI-RI-001) via Fed'x on 10/10/24 to US consignees. Philips Markets organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: To prevent the issue from occurring, Philips recommends that users not use the Perfusion Application Export function (as shown in Figure 4). When used without export functionality, the Perfusion Application performs as expected. " You may continue to use your system(s) in accordance with the intended use and by following th |
| Quantity | 2439 systems |
| 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 Mexic |
| FDA record | Open on fda.gov |