Haifa, N/A, Israel
Philips Medical Systems Technologies Ltd. recalls
1 recall recorded since 2018, most recently on 10 October 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 October 2024
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0497-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.