Recall Z-0497-2025— Philips Medical Systems Technologies Ltd.
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems Technologies Ltd., initiated 2024-10-10. It names 2 FDA 510(k) clearances: K153103, K110919. 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..
- Recalling firm
- Philips Medical Systems Technologies Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-10
- Firm location
- Haifa, N/A, Israel
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.